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    Clinical Trial Results:
    A Multicentre, Single-Arm, Open-Label Study of the Repeated Administration of Qutenza^TM (Capsaicin (8%) high-concentration patch) for the Treatment of Peripheral Neuropathic Pain (PNP)

    Summary
    EudraCT number
    2009-016457-18
    Trial protocol
    IE   FR   BE   GB   CZ   FI   ES   AT   IT   HU   NL   SK   PL   SI   GR  
    Global end of trial date
    26 Sep 2013

    Results information
    Results version number
    v2(current)
    This version publication date
    04 Jun 2016
    First version publication date
    23 May 2015
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Updates required due to non-substantial reasons

    Trial information

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    Trial identification
    Sponsor protocol code
    E05-CL-3001/STRIDE
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01252160
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Astellas Pharma Europe Ltd
    Sponsor organisation address
    2000 Hillswood Drive, Chertsey, United Kingdom, KT16 0RS
    Public contact
    Associate Medical Director - Pain Therapeutic Area, Astellas Pharma Europe Ltd, Astellas.resultsdisclosure@astellas.com
    Scientific contact
    Associate Medical Director - Pain Therapeutic Area, Astellas Pharma Europe Ltd, Astellas.resultsdisclosure@astellas.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Sep 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to assess the safety and efficacy of repeat applications of Qutenza TM (Capsaicin (8%) high-concentration patch) over 52 weeks in participants with Peripheral Neuropathic Pain (PNP).
    Protection of trial subjects
    This clinical study was written, conducted and reported in accordance with the protocol, ICH GCP Guidelines, and applicable local regulations, including the European Directive 2001/20/EC, on the protection of human rights, and with the ethical principles that have their origin in the Declaration of Helsinki.Astellas ensures that the use and disclosure of protected health information (PHI) obtained during a research study complies with the federal, national and/or regional legislation related to the privacy and protection of personal information. Approval for the study protocol, dated 30 Apr 2010, was obtained from the relevant competent authorities prior to study initiation.
    Background therapy
    Participants receiving first patch application could receive oral and transdermal opioid medication if it did not exceed a total oral daily dose of morphine of 80 mg or the equivalent, which was to be calculated using the Opioid Equivalence Guidance. Any changes, additions or discontinuations to medications were assessed and recorded at every study visit. A short acting opioid could be administered to relieve treatment-associated discomfort during and/or after treatment procedures, while the patient was in the clinic. Participants could receive concomitant systemic non-opioid pain medications for the treatment of Peripheral Neuropathic Pain(PNP).
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Oct 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 11
    Country: Number of subjects enrolled
    Poland: 8
    Country: Number of subjects enrolled
    Romania: 12
    Country: Number of subjects enrolled
    Slovakia: 5
    Country: Number of subjects enrolled
    Slovenia: 3
    Country: Number of subjects enrolled
    Spain: 33
    Country: Number of subjects enrolled
    United Kingdom: 73
    Country: Number of subjects enrolled
    Austria: 15
    Country: Number of subjects enrolled
    Belgium: 22
    Country: Number of subjects enrolled
    Czech Republic: 16
    Country: Number of subjects enrolled
    Finland: 13
    Country: Number of subjects enrolled
    France: 40
    Country: Number of subjects enrolled
    Greece: 9
    Country: Number of subjects enrolled
    Hungary: 5
    Country: Number of subjects enrolled
    Ireland: 7
    Country: Number of subjects enrolled
    Italy: 34
    Worldwide total number of subjects
    306
    EEA total number of subjects
    306
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    197
    From 65 to 84 years
    102
    85 years and over
    7

    Subject disposition

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    Recruitment
    Recruitment details
    This open-label, single-arm, multicenter study was conducted at 63 sites in Europe: 3 in Austria, 5 in Belgium, 4 in Czech Republic, 2 in Finland, 6 in France,2 in Greece, 1 in Hungary, 2 in Ireland, 9 in Italy, 2 in Netherlands, 3 in Poland, 2 in Romania, 1 in Slovakia, 2 in Slovenia, 10 in Spain, and 9 in the UK.

    Pre-assignment
    Screening details
    Study population consisted of 306 enrolled non-diabetic adult participants (18-90 years) with moderate to severe pain due to Peripheral Neuropathic Pain (PNP) with Postherpetic Neuralgia (PHN), HIV-associated Neuropathy (HIV-AN), Post-traumatic Nerve Injury (PNI) and Idiopatic Small Nerve Neuropathy (ISNN).

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    PHN [Post-herpetic Neuralgia]
    Arm description
    Participants with identified postherpetic neuralgia.
    Arm type
    Experimental

    Investigational medicinal product name
    Qutenza [Capsaicin (8%) high-concentration patch]
    Investigational medicinal product code
    ASP0805
    Other name
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Topical use
    Dosage and administration details
    Qutenza is a high-concentration (8%) capsaicin patch which was applied to intact, non-irritated, dry skin. Each patch contained a total of 179 mg of capsaicin or 640 μg of capsaicin per cm2 of patch (8%). Up to 4 patches (1120 cm2) could be applied at any 1 application.The patches were applied for 30 min (feet) or 60 min (other body locations). Patients were pre-treated with a local topical anesthetic (for a period as determined by the prescribing information of the product used) prior to the patch application. The choice of topical anesthetic was at the investigator’s discretion. After topical anesthetic was removed Qutenza was applied to painful area(s). Following removal of the patch treated area was cleaned with the gel provided.

    Arm title
    HIV-AN [Human Immunodeficiency Virus-associated Neuropathy]
    Arm description
    Participants with identified human immunodeficiency virus-associated neuropathy.
    Arm type
    Experimental

    Investigational medicinal product name
    Qutenza [Capsaicin (8%) high-concentration patch]
    Investigational medicinal product code
    ASP0805
    Other name
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Topical use
    Dosage and administration details
    Qutenza is a high-concentration (8%) capsaicin patch which was applied to intact, non-irritated, dry skin. Each patch contained a total of 179 mg of capsaicin or 640 μg of capsaicin per cm^2 of patch (8%). Up to 4 patches (1120 cm2) could be applied at any 1 application.The patches were applied for 30 min (feet) or 60 min (other body locations). Patients were pre-treated with a local topical anesthetic (for a period as determined by the prescribing information of the product used) prior to the patch application. The choice of topical anesthetic was at the investigator’s discretion. After topical anesthetic was removed Qutenza was applied to painful area(s). Following removal of the patch treated area was cleaned with the gel provided.

    Arm title
    PNI [Post-traumatic Nerve Injury]
    Arm description
    Participants with identified post-traumatic nerve injury.
    Arm type
    Experimental

    Investigational medicinal product name
    Qutenza [Capsaicin (8%) high-concentration patch]
    Investigational medicinal product code
    ASP0805
    Other name
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Topical use
    Dosage and administration details
    Qutenza is a high-concentration (8%) capsaicin patch which was applied to intact, non-irritated, dry skin. Each patch contained a total of 179 mg of capsaicin or 640 μg of capsaicin per cm^2 of patch (8%). Up to 4 patches (1120 cm^2) could be applied at any 1 application.The patches were applied for 30 min(feet) or 60 min (other body locations). Patients were pre-treated with a local topical anesthetic (for a period as determined by the prescribing information of the product used) prior to the patch application. The choice of topical anesthetic was at the investigator’s discretion. After topical anesthetic was removed Qutenza was applied to painful area(s). Following removal of the patch treated area was cleaned with the gel provided.

    Arm title
    Other type of Peripheral Neuropathic Pain [PNP]
    Arm description
    Participants with identified peripheral neuropathic pain.
    Arm type
    Experimental

    Investigational medicinal product name
    Qutenza [Capsaicin (8%) high-concentration patch]
    Investigational medicinal product code
    ASP0805
    Other name
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Topical use
    Dosage and administration details
    Qutenza is a high-concentration (8%) capsaicin patch which was applied to intact, non-irritated, dry skin. Each patch contained a total of 179 mg of capsaicin or 640 μg of capsaicin per cm^2 of patch (8%). Up to 4 patches (1120 cm^2) could be applied at any 1 application.The patches were applied for 30 min (feet) or 60 min (other body locations). Patients were pre-treated with a local topical anesthetic (for a period as determined by the prescribing information of the product used) prior to the patch application. The choice of topical anesthetic was at the investigator’s discretion. After topical anesthetic was removed Qutenza was applied to painful area(s). Following removal of the patch treated area was cleaned with the gel provided.

    Number of subjects in period 1
    PHN [Post-herpetic Neuralgia] HIV-AN [Human Immunodeficiency Virus-associated Neuropathy] PNI [Post-traumatic Nerve Injury] Other type of Peripheral Neuropathic Pain [PNP]
    Started
    107
    80
    99
    20
    Completed
    66
    45
    54
    11
    Not completed
    41
    35
    45
    9
         Other
    1
    5
    2
    1
         Lack of efficacy
    16
    8
    24
    6
         Protocol Violation
    3
    2
    1
    -
         Consent withdrawn by subject
    11
    13
    8
    1
         Adverse Event
    5
    1
    4
    1
         Lost to follow-up
    5
    6
    6
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PHN [Post-herpetic Neuralgia]
    Reporting group description
    Participants with identified postherpetic neuralgia.

    Reporting group title
    HIV-AN [Human Immunodeficiency Virus-associated Neuropathy]
    Reporting group description
    Participants with identified human immunodeficiency virus-associated neuropathy.

    Reporting group title
    PNI [Post-traumatic Nerve Injury]
    Reporting group description
    Participants with identified post-traumatic nerve injury.

    Reporting group title
    Other type of Peripheral Neuropathic Pain [PNP]
    Reporting group description
    Participants with identified peripheral neuropathic pain.

    Reporting group values
    PHN [Post-herpetic Neuralgia] HIV-AN [Human Immunodeficiency Virus-associated Neuropathy] PNI [Post-traumatic Nerve Injury] Other type of Peripheral Neuropathic Pain [PNP] Total
    Number of subjects
    107 80 99 20 306
    Age categorical
    The mean age of patients enrolled in the study was 57.9 years in the range from 20 to 90 years. The oldest patients were in the Postherpetic neuralgia (PHN) group with mean age 70.5 years and the range from 36 to 90 years. The youngest patients were in the Human immunodeficiency virus-associated neuropathy (HIV-AN) group with mean age of 51.5 years and the range of 22 to 76 years. The Post traumatic nerve injury (PNI) group had a mean age of 49.7 years and the age range from 20 to 81 years.
    Units: Subjects
        In utero
    0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0
        Adults (18-64 years)
    27 71 83 16 197
        From 65-84 years
    36 8 11 3 58
        85 years and over
    44 1 5 1 51
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    70.5 ± 10.85 51.5 ± 10.97 49.7 ± 13.48 56.5 ± 10.84 -
    Gender categorical
    Units: Subjects
        Female
    50 15 55 12 132
        Male
    57 65 44 8 174
    Brief Pain Inventory (BPI-DN Question 5) baseline average pain
    Brief Pain Inventory (BPI) questions are based on a scale of 1 (no pain) to 10 (pain as bad as can be imagined). BPI-DN Question 5 was used to assess participants baseline average pain.
    Units: Number
        arithmetic mean (standard deviation)
    6.2 ± 1.55 6.1 ± 1.75 6.6 ± 1.68 6.4 ± 1.38 -
    Time Since Diagnosis of Neuropathic Pain (Years)
    Time since diagnosis is defined as the date of baseline visit minus the date when diagnosis was made plus 1 day divided by 365.25. Time since diagnosis is presented for all groups, Human immunodeficiency virus-associated neuropathy (HIV-AN; N=79), Postherpetic neuralgia (PHN; N=107) and Post-traumatic nerve injury (PNI; N=99).
    Units: Years
        arithmetic mean (standard deviation)
    3.9 ± 4.97 7.4 ± 5.78 4 ± 4.34 7.7 ± 7.98 -

    End points

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    End points reporting groups
    Reporting group title
    PHN [Post-herpetic Neuralgia]
    Reporting group description
    Participants with identified postherpetic neuralgia.

    Reporting group title
    HIV-AN [Human Immunodeficiency Virus-associated Neuropathy]
    Reporting group description
    Participants with identified human immunodeficiency virus-associated neuropathy.

    Reporting group title
    PNI [Post-traumatic Nerve Injury]
    Reporting group description
    Participants with identified post-traumatic nerve injury.

    Reporting group title
    Other type of Peripheral Neuropathic Pain [PNP]
    Reporting group description
    Participants with identified peripheral neuropathic pain.

    Subject analysis set title
    Safety Analysis Set (SAF)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Safety Analysis Set (SAF) was defined and used for all analyses (both safety and efficacy) and it included all patients who received study patch application.

    Primary: Safety (Adverse Events[AE], Serious AEs [SAEs] and Treatment-Emergent AEs [TEAEs]) (SAF)

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    End point title
    Safety (Adverse Events[AE], Serious AEs [SAEs] and Treatment-Emergent AEs [TEAEs]) (SAF) [1]
    End point description
    This endpoint evaluated safety of repeated Qutenza (Capsaicin (8%) high-concentration patch) applications, including the effect in participants diagnosed with different types of PNP. There were 3 deaths reported in the study due to the events of cerebral hemorrhage,pneumonia and squamous cell carcinoma; all events leading to death were not related to Qutenza.
    End point type
    Primary
    End point timeframe
    Baseline to End of Treatment (EOT)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Adverse events (AEs) are summarized as counts over the entire study. Statistical analyses was not completed for this endpoint.
    End point values
    PHN [Post-herpetic Neuralgia] HIV-AN [Human Immunodeficiency Virus-associated Neuropathy] PNI [Post-traumatic Nerve Injury] Other type of Peripheral Neuropathic Pain [PNP]
    Number of subjects analysed
    107
    80
    99
    20
    Units: Number of participants
    number (not applicable)
        TEAE (Treatment Emergent Adverse Events)
    87
    62
    86
    17
        Drug-related TEAEs
    78
    42
    73
    14
        Deaths
    2
    1
    0
    0
        Serious TEAEs
    14
    8
    13
    2
        Drug-related serious TEAEs
    0
    0
    0
    0
        TEAEs leading to discontinuation
    5
    1
    4
    1
        Drug related TEAEs leading to discontinuation
    1
    0
    1
    1
        Application site reactions
    74
    30
    68
    13
    No statistical analyses for this end point

    Primary: Sensory Testing of most Sensitive Area(s) (Mean value, Area Size per Patch Application) (SAF)

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    End point title
    Sensory Testing of most Sensitive Area(s) (Mean value, Area Size per Patch Application) (SAF) [2]
    End point description
    This endpoint was used to complete sensory testing of most sensitive areas to which patches are applied. During this exam participants were assessed on change from the sensory assessments performed at the screening visit. Participants response to warm, cold, sharp (pinprick), vibration sensations, light brush, deep tendon reflexes, most sensitive areas, and allodynia were assesed at each patch application visit. Assessment was performed at week 26 (if applicable), End of Treatment (EOT) and planned or early termination visits. Data was reported for the Week 26, EOT and as a patient mean of all applications.
    End point type
    Primary
    End point timeframe
    Timeframe for this endpoint was by patch application (including last application) from Baseline to End of Treatement (EOT) at each patch application.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Sensory testing of the most sensitive area(s) and the corresponding areas of allodynia was assessed by location counts and absolute value of area size. Statistical analyses was not completed for this endpoint.
    End point values
    PHN [Post-herpetic Neuralgia] HIV-AN [Human Immunodeficiency Virus-associated Neuropathy] PNI [Post-traumatic Nerve Injury] Other type of Peripheral Neuropathic Pain [PNP]
    Number of subjects analysed
    107
    80
    99
    20
    Units: Number of participants
    arithmetic mean (standard deviation)
        Screening [N=107;79;98;19]
    325.8 ± 239.55
    615.8 ± 395.43
    182.3 ± 180.31
    411.6 ± 324.92
        1st Application [N=107;80;99;20]
    327.2 ± 235.22
    606.2 ± 371.64
    192.6 ± 191.65
    456.3 ± 303.77
        2nd Application [N=85;51;76;18]
    290.6 ± 206.64
    567.1 ± 344.79
    179.9 ± 208.69
    494.2 ± 327.82
        3rd Application [N=59;29;58;13]
    273.1 ± 225.55
    537.7 ± 360.03
    168.8 ± 193.42
    399.2 ± 301.67
        4th Application [N=35;16;39;10]
    281.5 ± 190.58
    488.9 ± 330.04
    149 ± 174.56
    335.8 ± 332.57
        5th Application [N=21;8;16;7]
    271.7 ± 221.54
    462.4 ± 290.25
    133.2 ± 151.15
    407.1 ± 368.18
        6th Application [N=6;1;6;3]
    270.7 ± 286.42
    1626 ± 0
    238.5 ± 254.25
    145.3 ± 59.97
        Last Application [N=107;80;99;20]
    307 ± 242.73
    604.6 ± 408.68
    193.9 ± 205.31
    446.6 ± 335.38
        Week 26 [N=107;80;99;20]
    288 ± 227.23
    587.6 ± 402.12
    189.9 ± 206.99
    446.6 ± 335.38
        EOT [N=106;80;99;20]
    254 ± 225.58
    558.6 ± 406.7
    183.9 ± 198.63
    430.8 ± 368.98
        Patient Mean (All Applications)
    294.4 ± 211.97
    586 ± 367.48
    184.5 ± 176.05
    460.9 ± 327.33
    No statistical analyses for this end point

    Secondary: Neurological Assessment (SAF)

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    End point title
    Neurological Assessment (SAF)
    End point description
    An abbreviated neurological examination was performed at the screening visit, at all patch application visits, at week 26 visit (if applicable), and at the planned or early termination visit. It included assessments of gait, muscle strength, and reflexes. The assessments were classified as normal, abnormal-not clinically significant and abnormal-clinically significant. Endpoint of interest was the number and percentage of participants with each neurological assessment score at the different study time points.
    End point type
    Secondary
    End point timeframe
    Baseline (Screening, All Patch application visits, Week 26) to End of Treatment (EOT)
    End point values
    PHN [Post-herpetic Neuralgia] HIV-AN [Human Immunodeficiency Virus-associated Neuropathy] PNI [Post-traumatic Nerve Injury] Other type of Peripheral Neuropathic Pain [PNP]
    Number of subjects analysed
    107
    80
    99
    20
    Units: Number of Participants
    number (not applicable)
        Scr Gait Normal [N=106;N=80;N=98;N=20]
    100
    53
    84
    17
        Scr Gait Abnormal NCS [N=106;N=80;N=98;N=20]
    6
    16
    10
    2
        Scr Gait Abnormal CS [N=106;N=80;N=98;N=20]
    0
    11
    4
    1
        Scr Muscle Strength Normal [N=106;N=79;N=99;N=20]
    104
    66
    91
    18
        Scr Muscle Strength Abn NCS [N=106;N=79;N=99;N=20]
    2
    9
    3
    2
        Scr Muscle Strength Abn CS [N=106;N=79;N=99;N=20]
    0
    4
    5
    0
        Scr Reflexes Normal [N=106;N=80;N=99;N=20]
    94
    32
    85
    13
        Scr Reflexes Abnormal NCS[N=106;N=80;N=99;N=20]
    9
    26
    9
    5
        Scr Reflexes Abnormal CS[N=106;N=80;N=99;N=20]
    3
    22
    5
    2
        W26 Gait Normal[N=107;N=80;N=99;N=20]
    7
    5
    4
    0
        W26 Gait Abnormal NCS[N=107;N=80;N=99;N=20]
    0
    3
    0
    0
        W26 Gait Abnormal CS[N=107;N=80;N=99;N=20]
    0
    0
    0
    0
        W26 Muscle Strength Normal[N=107;N=80;N=99;N=20]
    7
    6
    3
    0
        W26 Muscle Strength Abnor NCS[N=107;N=80;N=99;N=20
    0
    2
    0
    0
        W26 Muscle Strength Abnor CS[N=107;N=80;N=99;N=20]
    0
    0
    1
    0
        W26 Reflexes Normal[N=107;N=80;N=99;N=20]
    6
    4
    4
    0
        W26 Reflexes Abnormal NCS[N=107;N=80;N=99;N=20]
    0
    4
    0
    0
        W26 Reflexes Abnormal CS[N=107;N=80;N=99;N=20]
    1
    0
    0
    0
        EOT Gait Normal[N=106;N=80;N=98;N=20]
    99
    60
    88
    18
        EOT Gait Abnormal NCS[N=106;N=80;N=98;N=20]
    7
    16
    3
    2
        EOT Gait Abnormal CS[N=106;N=80;N=98;N=20]
    0
    4
    7
    0
        EOT Muscle Strength Normal[N=106;N=80;N=98;N=20]
    104
    72
    90
    19
        EOT Muscle Strength Abn NCS[N=106;N=80;N=98;N=20]
    2
    6
    2
    1
        EOT Muscle Strength Abn CS[N=106;N=80;N=98;N=20]
    0
    2
    7
    0
        EOT Reflexes Normal[N=106;N=80;N=99;N=20]
    95
    29
    89
    14
        EOT Reflexes Abn NCS [N=106;N=80;N=99;N=20]
    9
    38
    6
    3
        EOT Reflexes Abn CS [N=106;N=80;N=99;N=20]
    2
    13
    4
    3
    No statistical analyses for this end point

    Secondary: Change from Baseline Vital Signs (SAF)

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    End point title
    Change from Baseline Vital Signs (SAF)
    End point description
    Before All Applications (Before App) is assessed within 15 minutes prior to application of topical anesthetic and After All Applications (After App) within 5 minutes after patch removal. Sys Blood pressure=Systolic Blood Pressure. Dia Blood Press=Diastolic Blood Pressure. Participants for PHN group Before Subject Mean (all applications) N=106; After Subject Mean (all applications) N=107; Week 26; N=7 and EOT N=107. Participants for HIV-AN group for Before Subject Mean (all applications) N=79; After Subject Mean (all applications) N=79; Week 26; N=9 and EOT N=79. For PNI group Before Subject Mean (all applications) N=99; After Subject Mean (all applications) N=99; Week 26; N=4 and EOT N=99. For "Other" number of participants is as follows Before Subject Mean (all applications) N=20; After Subject Mean (all applications) N=20; Week 26; N=0 and EOT N=20. For group Other (describing other neuropathic pain) Week 26 values are not available for Systolic, Diastolic and Pulse rate.
    End point type
    Secondary
    End point timeframe
    Baseline to End of Treatment (EOT). Vital signs, including BP and PR were measured at screening, at all patch application visits (within 15 min prior to application of topical anesthetic and within 5 min after patch removal) and week 26 visit and EOT.
    End point values
    PHN [Post-herpetic Neuralgia] HIV-AN [Human Immunodeficiency Virus-associated Neuropathy] PNI [Post-traumatic Nerve Injury] Other type of Peripheral Neuropathic Pain [PNP]
    Number of subjects analysed
    107
    80
    99
    20
    Units: Number
    arithmetic mean (standard deviation)
        Sys Blood Press [Before App Subject Mean]
    -1.9 ± 14.3
    -1.1 ± 14.67
    0.6 ± 11.57
    2.3 ± 16.09
        Sys Blood Press [After App Subject Mean]
    6.2 ± 16.54
    -0.3 ± 15.3
    2.2 ± 13.7
    4.4 ± 13.67
        Sys Blood Press Week 26
    10.1 ± 10.73
    -9.2 ± 19.41
    0.5 ± 3.32
    0 ± 0
        Sys Blood Press EOT
    -1.5 ± 16.89
    -2.2 ± 17.05
    1.4 ± 15.96
    -1.9 ± 18.92
        Dia Blood Press [Before App Subject Mean]
    -2.1 ± 9.48
    -1.2 ± 9.24
    0 ± 9.69
    -0.2 ± 9.35
        Dia Blood Press [After App Subject Mean]
    1.3 ± 11.06
    0.1 ± 9.1
    0.6 ± 10.36
    2.8 ± 9.43
        Dia Blood Press Week 26
    0.9 ± 5.67
    -3.6 ± 15.49
    -1.3 ± 6.75
    0 ± 0
        Dia Blood Press EOT
    -1.7 ± 11.35
    -1.9 ± 11.02
    0.4 ± 11.77
    -2.6 ± 10.19
        Pulse Rate [Before App Subject Mean]
    -0.3 ± 10.03
    0.1 ± 10.88
    -0.6 ± 8.99
    -1.6 ± 8.17
        Pulse Rate [After App Subject Mean]
    -1.6 ± 10.58
    -1.4 ± 9.54
    -0.8 ± 9.8
    -1.8 ± 8.27
        Pulse Rate Week 26
    -9.1 ± 10.73
    2.9 ± 11.65
    -5.5 ± 6.66
    0 ± 0
        Pulse Rate EOT
    0.1 ± 12.6
    0.6 ± 13.36
    1.9 ± 11.18
    -1.7 ± 10.59
    No statistical analyses for this end point

    Secondary: Dermal Assessment at Patch Applications (SAF)

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    End point title
    Dermal Assessment at Patch Applications (SAF)
    End point description
    Dermal assessment was done at patch applications to determine if there were any signs of irritation.It was completed at all patch application visits (prior to application of topical anesthetic, within 5 min and 60 min after patch removal), at week 26 visit (if applicable), and at the EOT or early termination visits. Scale for assessment was based on a 0 to 7 point severity score. The endpoints of interest were counts by category as listed; [No evidence of irritation], [Minimal erythema barely perceptive],[Definite erythema, readily visible; minimal and edema or minimal popular response],[Erythema and papules],[Definite edema],[Erythema, edema, and papules],[Vesicular eruption],[Strong reaction spreading beyond test site] and [Combined category >= 4 (definite edema or higher)].
    End point type
    Secondary
    End point timeframe
    Baseline to End of Treatment (EOT).
    End point values
    PHN [Post-herpetic Neuralgia] HIV-AN [Human Immunodeficiency Virus-associated Neuropathy] PNI [Post-traumatic Nerve Injury] Other type of Peripheral Neuropathic Pain [PNP]
    Number of subjects analysed
    107
    80
    99
    20
    Units: Number of Participants
    number (not applicable)
        1st App Before anesthetic[Combined category >=4]
    0
    0
    0
    0
        1st App 5min after patch[Combined category >= 4]
    6
    2
    5
    0
        1st App 60min after patch[Combined category >= 4]
    5
    1
    4
    0
        2nd App Before anesthetic[Combined category >= 4]
    0
    0
    0
    0
        2nd App 5min after patch[Combined category >= 4]
    6
    0
    3
    0
        2nd App 60min after patch[Combined category >= 4]
    3
    1
    4
    0
        3rd App Before anesthetic[Combined category >= 4]
    0
    0
    0
    0
        3rd App 5min after patch[Combined category >= 4]
    1
    0
    2
    0
        3rd App 60min after patch[Combined category >= 4]
    1
    0
    1
    0
        4th App Before anesthetic[Combined category >= 4]
    0
    0
    0
    0
        4th App 5min after patch[Combined category >= 4]
    0
    0
    1
    0
        4th App 60min after patch[Combined category >= 4]
    0
    0
    0
    0
        5th App Before anesthetic[Combined category >= 4]
    0
    0
    0
    0
        5th App 5min after patch[Combined category >= 4]
    0
    0
    0
    0
        5th App 60min after patch[Combined category >= 4]
    0
    0
    0
    0
        6th App Before anesthetic[Combined category >= 4]
    0
    0
    0
    0
        6th App 5min after patch[Combined category >= 4]
    0
    0
    0
    0
        6th App 60min after patch[Combined category >= 4]
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline Brief Pain Inventory Question 5 (average pain)(SAF)

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    End point title
    Change from Baseline Brief Pain Inventory Question 5 (average pain)(SAF)
    End point description
    Responses to BPI Question 5 (average pain) were recorded daily and weekly (± 2 days) from the 1st patch application until the planned or early termination visit. Weekly response was recorded on the day chosen by patient during the 1st patch application visit (± 2 days). Each BPI item uses a 0 to 10 rating scale anchored at zero for“no pain”and 10 for “pain as bad as you can imagine” for severity and “does not interfere” to “completely interferes” for interference. Number of participants for each month was as follows; Month 1[N=106;79;99;20]; Month 2[N=102;69;95;19];Month 3[N=97;65;89;18];Month 4[N=91;64;89;18];Month 5[N=90;58;79;18];Month 6[N=81;59;77;16];Month 7[N=79;58;72;15]; Month 8[N=75;56;69;15]; Month 9[N=70;49;69;14]; Month 10[N=70;47;64;12]; Month 11[N=68;43;60;11]; Month 12[N=63;42;58;11];Month 13[N=54;41;49;9];Month 14[N=42;29;44;5]; Month 15[N=23;21;25;3]; Month 16[N=8;6;3;2]; Month 17[N=2;2;1;1]; Month 18[N=1;0;1;1]; Month 19[N=1;0;1;0];Month 20[N=1;0;0;0].
    End point type
    Secondary
    End point timeframe
    Baseline to End of Treatment (EOT).
    End point values
    PHN [Post-herpetic Neuralgia] HIV-AN [Human Immunodeficiency Virus-associated Neuropathy] PNI [Post-traumatic Nerve Injury] Other type of Peripheral Neuropathic Pain [PNP]
    Number of subjects analysed
    107
    80
    99
    20
    Units: Number of Participants
    arithmetic mean (standard deviation)
        Month 1 Post-baseline
    -0.9 ± 1.25
    -0.7 ± 1.3
    -1.1 ± 1.49
    -0.6 ± 1.07
        Month 2 Post-baseline
    -1 ± 1.41
    -1.1 ± 1.52
    -1.3 ± 1.89
    -0.7 ± 0.96
        Month 3 Post-baseline
    -1 ± 1.35
    -1 ± 1.57
    -1.3 ± 1.69
    -0.7 ± 1.06
        Month 4 Post-baseline
    -1.3 ± 1.54
    -1.3 ± 1.96
    -1.6 ± 1.71
    -0.9 ± 1.12
        Month 5 Post-baseline
    -1.4 ± 1.51
    -1.3 ± 1.81
    -1.6 ± 1.93
    -1 ± 1.36
        Month 6 Post-baseline
    -1.4 ± 1.61
    -1.1 ± 1.83
    -1.9 ± 1.89
    -0.8 ± 1.05
        Month 7 Post-baseline
    -1.5 ± 1.76
    -1.2 ± 1.86
    -2 ± 1.89
    -0.9 ± 1.32
        Month 8 Post-baseline
    -1.6 ± 1.75
    -1.2 ± 1.74
    -2.2 ± 2.04
    -1.3 ± 1.46
        Month 9 Post-baseline
    -1.5 ± 1.99
    -1.2 ± 1.75
    -2 ± 2.12
    -1.5 ± 1.34
        Month 10 Post-baseline
    -1.6 ± 1.96
    -1.3 ± 1.58
    -1.9 ± 2.06
    -1.7 ± 1.71
        Month 11 Post-baseline
    -1.7 ± 2.01
    -1.5 ± 1.62
    -2 ± 2.21
    -1.4 ± 1.67
        Month 12 Post-baseline
    -1.7 ± 1.92
    -1.5 ± 1.83
    -2.3 ± 2.19
    -2.1 ± 1.56
        Month 13 Post-baseline
    -1.8 ± 1.87
    -1.8 ± 2.09
    -2.3 ± 2.23
    -2.2 ± 1.85
        Month 14 Post-baseline
    -1.6 ± 1.96
    -1.5 ± 1.72
    -2.1 ± 2.47
    -2.5 ± 2.17
        Month 15 Post-baseline
    -1.6 ± 2.32
    -1.9 ± 1.66
    -1.7 ± 2.09
    -0.8 ± 1.45
        Month 16 Post-baseline
    -2.6 ± 2.04
    -2.3 ± 2.69
    0.6 ± 0.93
    -1.8 ± 0.71
        Month 17 Post-baseline
    -1.8 ± 2.21
    -0.9 ± 0.09
    -0.3 ± 99999
    -2.9 ± 99999
        Month 18 Post-baseline
    -2.8 ± 99999
    0 ± 0
    0.2 ± 99999
    -2.9 ± 99999
        Month 19 Post-baseline
    -3.6 ± 99999
    0 ± 0
    0.2 ± 99999
    0 ± 99999
        Month 20 Post-baseline
    -3 ± 99999
    0 ± 0
    0 ± 0
    0 ± 0
    No statistical analyses for this end point

    Secondary: Tolerability of patch application (SAF)

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    End point title
    Tolerability of patch application (SAF)
    End point description
    Analyses of tolerability include summaries of the percent of intended patch application time overall and by patients’ individual neuropathic diagnosis. Duration of patch application was the difference between the stop and start times, and it was presented as a percentage of intended patch application duration. The proportion of patients completing at least 90% of the intended patch application were reported at each patch application. Additionally, a patient was deemed to have had an early patch removal if they had an AE with study drug action of temporary discontinuation, if the patch application duration was less than 100%, or if the patient went on to receive additional subsequent patch applications.
    End point type
    Secondary
    End point timeframe
    Duration of patch application was the difference between the stop and start times.
    End point values
    PHN [Post-herpetic Neuralgia] HIV-AN [Human Immunodeficiency Virus-associated Neuropathy] PNI [Post-traumatic Nerve Injury] Other type of Peripheral Neuropathic Pain [PNP]
    Number of subjects analysed
    107
    80
    99
    20
    Units: Number
    arithmetic mean (standard deviation)
        Time to 2nd patch application(days)[N=85;51;76;18]
    98.3 ± 49.79
    111.1 ± 43.57
    94.8 ± 47.02
    84.3 ± 24.62
        Time to 3rd patch application(days)[N=59;29;58;13]
    103.3 ± 40.94
    127.3 ± 55.56
    107.9 ± 44.87
    104.8 ± 28.7
        Time to 4th patch application(days)[N=35;16;39;10]
    94.7 ± 29.08
    110.1 ± 35.61
    103.8 ± 28.19
    80 ± 12.78
        Time to 5th patch application(days)[N=21;8;16;7]
    89.8 ± 22.06
    79.4 ± 7.91
    83.3 ± 19.38
    74.4 ± 12.42
        Time to 6th patch application(days)[N=6;1;6;3]
    85 ± 32.54
    91 ± 0
    74.8 ± 10.98
    70 ± 10.39
    No statistical analyses for this end point

    Secondary: Change from Baseline Brief Pain Inventory (BPI) Question 6 (pain now)(SAF)

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    End point title
    Change from Baseline Brief Pain Inventory (BPI) Question 6 (pain now)(SAF)
    End point description
    Brief Pain Inventory (BPI) Question 6 (pain now) was used to assess participants pain now. Participants completed questionaire with numeric rating scale measuring severity of pain and its interference with daily function on a 0-10 rating scale,using 0 to identify “no pain” and 10 “pain as bad as you can imagine”. Data reported is subject mean of all applications before each patch application and to within 5 min and after 1 hour after each patch application.
    End point type
    Secondary
    End point timeframe
    Response to BPI Question 6 (pain now) was recorded before topical anesthetic application, within 5 min following patch removal, and after 1 hour following patch removal.
    End point values
    PHN [Post-herpetic Neuralgia] HIV-AN [Human Immunodeficiency Virus-associated Neuropathy] PNI [Post-traumatic Nerve Injury] Other type of Peripheral Neuropathic Pain [PNP]
    Number of subjects analysed
    107
    80
    99
    20
    Units: Number
    arithmetic mean (standard deviation)
        Subject Mean All Applications [Prior to patch]
    -0.5 ± 1.15
    -0.2 ± 0.83
    -0.4 ± 0.85
    -0.2 ± 1.18
        Subject Mean All Applications [5 min after patch]
    0.6 ± 2.28
    -0.7 ± 2.35
    -0.3 ± 2.32
    -0.6 ± 1.54
        Subject Mean All Applications [1 hour after patch]
    -0.7 ± 2.2
    -1 ± 2.3
    -1 ± 2.22
    -1 ± 1.57
    No statistical analyses for this end point

    Secondary: Patient Global Impression of Change (PGIC) for combined category of very much improved + much improved + minimally improved (SAF)

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    End point title
    Patient Global Impression of Change (PGIC) for combined category of very much improved + much improved + minimally improved (SAF)
    End point description
    The Patient Global Impression of Change (PGIC) is a patient-rated instrument that measures change in participants overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Data reported is the precentage of participants who reported improvement in their overall status (combined category of very much improved + much improved + minimally improved) for each application. Participants answered a PGIC questionnaire at patch application visits (except 1st patch application visit) and 4 weeks after each patch application visit, at week 26 visit (if applicable), and at the planned or early termination visit.
    End point type
    Secondary
    End point timeframe
    Baseline to End of Treatment (EOT). Safety Analysis Set (SAF).
    End point values
    PHN [Post-herpetic Neuralgia] HIV-AN [Human Immunodeficiency Virus-associated Neuropathy] PNI [Post-traumatic Nerve Injury] Other type of Peripheral Neuropathic Pain [PNP]
    Number of subjects analysed
    107
    80
    99
    20
    Units: percent
    number (not applicable)
        1st App [4 weeks after]
    61.5
    54.5
    67.4
    47.1
        2nd App [Prior to patch application]
    47.9
    55.3
    68.3
    50
        2nd App [4 weeks after]
    67.7
    76.9
    81.5
    69.2
        3rd App [Prior to patch application]
    80.9
    70.8
    73.5
    75
        3rd App [4 weeks after]
    69
    75
    73.3
    72.7
        4th App [Prior to patch application]
    66.7
    100
    83.3
    88.9
        4th App [4 weeks after]
    80
    91.7
    71.9
    87.5
        5th App [Prior to patch application]
    94.7
    88.9
    80
    83.3
        5th App [4 weeks after]
    87.5
    85.7
    66.7
    83.3
        6th App [Prior to patch application]
    80
    0
    66.7
    66.7
        6th App [4 weeks after]
    100
    0
    60
    66.7
        Last App [Prior to patch application]]
    57.9
    65.1
    70.8
    71.4
        Last App [4 weeks after]
    57.7
    53.8
    65.4
    52.9
    No statistical analyses for this end point

    Secondary: Change from Baseline EQ-5D VAS Questionnaire (SAF)

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    End point title
    Change from Baseline EQ-5D VAS Questionnaire (SAF)
    End point description
    The EQ-5D is used as a measure of participants health-related quality of life (HRQoL) on a visual analog scale (VAS) on a graduated (0 to 100) scale, with higher scores for higher HRQoL.The EQ-5D self-reported questionnaire includes a VAS, which records the respondent’s self-rated health status on a graduated (0 to 100) scale, with higher scores for higher HRQoL. It also includes the EQ-5D descriptive system, which comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each of the 5 dimensions is assessed in 3 levels: “no problems”, “some problems”, or “extreme problems/unable to perform activity”. Data represented is the subject mean of all applications from Baseline to EOT.
    End point type
    Secondary
    End point timeframe
    Baseline to End of Treatment [EOT]
    End point values
    PHN [Post-herpetic Neuralgia] HIV-AN [Human Immunodeficiency Virus-associated Neuropathy] PNI [Post-traumatic Nerve Injury] Other type of Peripheral Neuropathic Pain [PNP]
    Number of subjects analysed
    107
    80
    99
    20
    Units: Number
    arithmetic mean (standard deviation)
        All App[Prior to Patch App N=74 N=39 N=66 N=14]
    0.3 ± 18.2
    3.4 ± 16.16
    -1.8 ± 15.2
    0.1 ± 10.82
        All App[4 Weeks After N=86 N=55 N=86 N=16]
    1.9 ± 24.71
    3 ± 31.75
    1.9 ± 24.02
    -2.2 ± 14.75
    No statistical analyses for this end point

    Secondary: Change from Baseline HADS (Hospital Anxiety and Depression Scale)(SAF)

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    End point title
    Change from Baseline HADS (Hospital Anxiety and Depression Scale)(SAF)
    End point description
    The HADS is a self-report scale developed for the assessment of anxiety and depression in non-psychiatric populations. In this study it was used to screen for the presence of moderate to severe depressive symptomatology and to assess co-morbid depression during the course of the study. It contains 14 items rated on a 4-point Likert-type scale. There are 2 sub-scales, one assessing depression and the other anxiety. The 7-item depression and anxiety subscales yield scores of 0 to 21 that are interpreted with the following cut-off points: 0 to 7, normal; 8 to 10, mild mood disturbance; 11 to 14, moderate mood disturbance; and 15 to 21, severe mood disturbance. Full Analysis Set (FAS) was used for analysis and data presented represents change from baseline.
    End point type
    Secondary
    End point timeframe
    Baseline to End of Treatment [EOT}.
    End point values
    PHN [Post-herpetic Neuralgia] HIV-AN [Human Immunodeficiency Virus-associated Neuropathy] PNI [Post-traumatic Nerve Injury] Other type of Peripheral Neuropathic Pain [PNP]
    Number of subjects analysed
    107
    80
    99
    20
    Units: Number
    arithmetic mean (standard deviation)
        1st App 4 weeks after[N=82;51;84;15]
    -0.5 ± 3.28
    0.6 ± 3.57
    -0.5 ± 2.97
    -0.7 ± 2.94
        2nd App Prior to patch[N=72;34;60;14]
    -1.1 ± 2.82
    -0.7 ± 3.01
    -0.6 ± 3.07
    -2.1 ± 2.4
        2nd App 4 weeks after[N=60;24;54;13]
    -0.8 ± 3.16
    -0.3 ± 3.43
    -1.3 ± 3.13
    -1.8 ± 2.62
        3rd App Prior to patch[N=46;21;49;11]
    -0.7 ± 2.99
    -0.2 ± 2.68
    -1 ± 3.11
    -1.5 ± 2.77
        3rd App 4 weeks after[N=43;13;44;11]
    -0.6 ± 2.95
    -0.9 ± 3.8
    -0.9 ± 3.37
    -1 ± 3.1
        4th App Prior to patch[N=30;11;36;8]
    -1.1 ± 3.03
    -2.3 ± 3.2
    -1.6 ± 3.21
    -1.1 ± 2.1
        4th App 4 weeks after[N=24;12;33;8]
    -0.3 ± 3.03
    -0.3 ± 3.98
    -0.7 ± 2.8
    -0.5 ± 1.6
        5th App Prior to patch[N=19;8;16;5]
    -1.3 ± 3.07
    0.5 ± 4.21
    -1.6 ± 3.61
    -0.6 ± 1.67
        5th App 4 weeks after[N=16;7;12;6]
    -1.3 ± 2.89
    0.7 ± 4.5
    -0.7 ± 4.01
    -1.7 ± 3.39
        6th App Prior to patch[N=5;0;6;3]
    -0.4 ± 4.56
    0 ± 0
    2.5 ± 3.02
    -1.3 ± 2.89
        6th App 4 weeks after[N=4;0;5;3]
    -1.8 ± 3.86
    0 ± 0
    1.2 ± 4.02
    -1.3 ± 0.58
        Last App Prior to patch[N=73;38;64;13]
    -0.6 ± 2.91
    -0.7 ± 2.78
    -1 ± 3.45
    -1.5 ± 2.4
        Last App 4 weeks after[N=74;47;78;16]
    -0.5 ± 3.27
    -0.1 ± 3.5
    -0.8 ± 3.54
    -1 ± 3.16
    No statistical analyses for this end point

    Secondary: Change from Baseline WPAI:NP (Work Productivity and Activity Impairment Questionnaire )Items 2-6 Scores(SAF)

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    End point title
    Change from Baseline WPAI:NP (Work Productivity and Activity Impairment Questionnaire )Items 2-6 Scores(SAF)
    End point description
    The WPAI:NP is a self-report scale developed for the assessment of work productivity and activity impairment related to neuropathic pain. It contains 6 items. The 1st item asks if the patient is currently working. Items 2 to 4 ask for responses in terms of the number of hours during the past 7 days associated with various activities. Items 5 and 6 are rated on a 10-point Likert-type scale ranging from “problem had no effect on my work/daily activities” to “problem completely prevented me from doing my work/daily activities”. Safety Analysis Set (SAF) was used for analysis and data represented shows change from baseline represented as subject mean of all applications to questions 2-6.
    End point type
    Secondary
    End point timeframe
    Baseline to End of Treatment [EOT].
    End point values
    PHN [Post-herpetic Neuralgia] HIV-AN [Human Immunodeficiency Virus-associated Neuropathy] PNI [Post-traumatic Nerve Injury] Other type of Peripheral Neuropathic Pain [PNP]
    Number of subjects analysed
    107
    80
    99
    20
    Units: Number
    arithmetic mean (standard deviation)
        Q2 Mean All App Prior to patch[N=6;11;27;5]
    -5 ± 10.61
    -4 ± 9.66
    -1.4 ± 8.69
    6.5 ± 6.59
        Q2 Mean All App 4 weeks after [N=8;15;34;5]
    -1.4 ± 12.56
    4.6 ± 37.99
    -1.2 ± 14.21
    5.7 ± 8.69
        Q3 Mean All App Prior to patch[N=6;11;27;5]
    -2 ± 15.27
    -0.5 ± 1.98
    -1.2 ± 6.6
    3 ± 6.71
        Q3 Mean All App 4 weeks after[N=8;15;34;5]
    -0.9 ± 17.32
    3.9 ± 14.59
    4.6 ± 16.8
    5.8 ± 6.52
        Q4 Mean All App Prior to patch[N=6;11;27;5]
    -1.8 ± 17.15
    -3.7 ± 14.92
    1.9 ± 9.79
    2.3 ± 3.72
        Q4 Mean All App 4 weeks after[N=8;15;34;5]
    4.1 ± 12.76
    -6.9 ± 24.01
    -2.2 ± 20.98
    4 ± 14.25
        Q5 Mean All App Prior to patch[N=6;8;23;4]
    -0.9 ± 0.82
    -0.4 ± 0.65
    -0.7 ± 1.26
    -1.3 ± 1.7
        Q5 Mean all App 4 weeks after[N=8;12;27;4]
    -0.6 ± 0.71
    -0.9 ± 1.29
    -0.8 ± 1.74
    -1.8 ± 3.25
        Q6 Mean All App Prior to patch[N=74;39;66;14]
    -0.6 ± 1.59
    -0.6 ± 1.1
    -0.8 ± 1.41
    -0.6 ± 0.97
        Q6 Mean All App 4 weeks after[N=86;55;86;16]
    -0.5 ± 2.44
    -0.9 ± 1.76
    -1.2 ± 2.27
    -0.8 ± 1.33
    No statistical analyses for this end point

    Secondary: Self-assessment of Treatment (SAT) (SAF)

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    End point title
    Self-assessment of Treatment (SAT) (SAF)
    End point description
    Participants answered a SAT questionnaire at week 26 (if applicable) and the planned or early termination visit. The SAT assesses treatment satisfaction by using a 5-point Likert-type scale ranging from -2 (a strong negative response) to 2 (a strong positive response); zero indicates a neutral response. The questionnaire contains each of the following questions: 1. How do you assess your pain level after treatment in this study? 2. How do you assess your activity level after treatment in this study? 3. How has your quality of life changed after treatment in this study? 4. Would you undergo this treatment again? 5. How do you compare the treatment you received in this study to previous medication or therapies for your pain?. Data was represented by counts in combined categories [Worse: (-2) + (-1)] [Not Better or Worse: (-2) + (-1) + (0)] and [Better: (1) + (2).
    End point type
    Secondary
    End point timeframe
    Baseline to End of Treatment (EOT)
    End point values
    PHN [Post-herpetic Neuralgia] HIV-AN [Human Immunodeficiency Virus-associated Neuropathy] PNI [Post-traumatic Nerve Injury] Other type of Peripheral Neuropathic Pain [PNP]
    Number of subjects analysed
    107
    80
    99
    20
    Units: Number of participants
    number (not applicable)
        Pain Level [Worse] [N=71;48;65;17]
    7
    6
    10
    2
        Pain Level [Not Better or Worse] [N=71;48;65;17]
    26
    20
    23
    8
        Pain Level [Better] [N=71;48;65;17]
    38
    22
    32
    7
        Activity Level [Worse] [N=71;48;65;17]
    13
    10
    12
    2
        Activity Level[Not Better or Worse][N=71;48;65;17]
    38
    23
    34
    10
        Activity Level [Better] [N=71;48;65;17]
    20
    15
    19
    5
        Quality of Life[Worse][N=71;48;65;17]
    6
    5
    6
    0
        Quality of Life[Not Better orWorse][N=71;48;65;17]
    40
    27
    28
    11
        Quality of Life[Better][N=71;48;65;17]
    25
    16
    31
    6
        Treatment again[Worse][N=71;48;65;17]
    22
    16
    22
    9
        Treatment again[Not Better orWorse][N=71;48;65;17]
    14
    7
    10
    0
        Treatment again[Better][N=71;48;65;17]
    35
    25
    33
    8
        Compare treatment[Worse][N=71;48;65;17]
    15
    8
    15
    4
        Compare treatment[Not Better Worse][N=71;48;65;17]
    24
    20
    14
    7
        Compare treatment[Better][N=71;48;65;17]
    32
    20
    36
    6
    No statistical analyses for this end point

    Secondary: Use of Concomitant Pain Medication following Patch Application(SAF)

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    End point title
    Use of Concomitant Pain Medication following Patch Application(SAF)
    End point description
    Concomitant medication use was assessed throughout the study, from Baseline to End of Treatment or early termination visit. Classes of interest were: chronic medication for neuropathic pain, antidepressants, antiepileptic drugs, and opioids. Data presented reflects concomitant medication post-application used on days 1 through 5 after patch application.
    End point type
    Secondary
    End point timeframe
    Baseline to End of Treatment[EOT]
    End point values
    PHN [Post-herpetic Neuralgia] HIV-AN [Human Immunodeficiency Virus-associated Neuropathy] PNI [Post-traumatic Nerve Injury] Other type of Peripheral Neuropathic Pain [PNP]
    Number of subjects analysed
    107
    80
    99
    20
    Units: Number of Participants
    number (not applicable)
        ANALGESICS
    42
    23
    36
    5
        ANESTHETICS
    4
    1
    5
    0
        ANTIEPILEPTICS
    1
    1
    0
    0
        ANTIHISTAMINES FOR SYSTEMIC USE
    1
    1
    0
    0
        ANTIINFLAMMATORY AND ANTIRHEUMATIC
    11
    2
    8
    0
        ANTIPRURITICS, INCL ANTIHISTAMINES, ANESTHETICS
    0
    1
    0
    0
        CARDIAC THERAPY
    3
    3
    2
    0
        COUGH AND COLD PREPARATIONS
    0
    4
    1
    0
        DRUGS FOR CONSTIPATION
    3
    1
    0
    0
        EMOLLIENTS AND PROTECTIVES
    3
    1
    0
    0
        OPHTHALMOLOGICALS
    8
    1
    6
    0
        OTHER DERMATOLOGICAL PREPARATIONS
    7
    1
    6
    0
        OTHER GYNECOLOGICALS
    3
    2
    2
    0
        OTOLOGICALS
    0
    1
    0
    0
        STOMATOLOGICAL PREPARATIONS
    10
    1
    6
    0
        THROAT PREPARATIONS
    0
    1
    0
    0
        TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
    10
    2
    8
    0
        UNSPECIFIED HERBAL AND TRADITIONAL MEDICINE
    3
    1
    0
    0
        UROLOGICALS
    0
    1
    0
    0
        VASOPROTECTIVES
    0
    1
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) are summarized as counts over the entire study and by patch application. Within each of these time periods AEs are summarized overall and by individual neuropathic diagnosis. Only TEAEs were analyzed in this study.
    Adverse event reporting additional description
    Each AE was categorized based on which patch applications it occurred between (i.e.,between 1st and 2nd, between 2nd and 3rd, etc., or after last). Each AE was additionally categorized based on whether it occurred within 7 days after a patch application, and also based on whether it occurred more than 7 days after a patch application.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13.1.
    Reporting groups
    Reporting group title
    PHN [Postherpetic Neuralgia]
    Reporting group description
    -

    Reporting group title
    HIV-AN [Human Immunodeficiency Virus-associated Neuropathy]
    Reporting group description
    -

    Reporting group title
    PNI [Post-Traumatic Nerve Injury]
    Reporting group description
    -

    Reporting group title
    Other type of Peripheral Neuropathic Pain [PNP]
    Reporting group description
    -

    Serious adverse events
    PHN [Postherpetic Neuralgia] HIV-AN [Human Immunodeficiency Virus-associated Neuropathy] PNI [Post-Traumatic Nerve Injury] Other type of Peripheral Neuropathic Pain [PNP]
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 107 (13.08%)
    8 / 80 (10.00%)
    13 / 99 (13.13%)
    2 / 20 (10.00%)
         number of deaths (all causes)
    2
    1
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Aortic dissection
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 80 (1.25%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    1 / 99 (1.01%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    1 / 99 (1.01%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Chemotherapy
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip arthroplasty
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip surgery
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Knee arthroplasty
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    1 / 99 (1.01%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal laminectomy
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    B-cell unclassifiable lymphoma high grade
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    2 / 107 (1.87%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    1 / 99 (1.01%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    2 / 107 (1.87%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    1 / 99 (1.01%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Biopsy
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 80 (0.00%)
    1 / 99 (1.01%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biopsy bone
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 80 (1.25%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    1 / 99 (1.01%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Complex regional pain syndrome
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    1 / 99 (1.01%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 80 (1.25%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuralgia
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    1 / 99 (1.01%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    1 / 99 (1.01%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    1 / 99 (1.01%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 80 (1.25%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal ulcer haemorrhage
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 80 (1.25%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    1 / 99 (1.01%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Bladder disorder
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 80 (1.25%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    1 / 99 (1.01%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 80 (1.25%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fistula
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    1 / 99 (1.01%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mobility decreased
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 80 (1.25%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muskuloskeletal chest pain
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    1 / 99 (1.01%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 80 (1.25%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    1 / 99 (1.01%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HIV peripheral neuropathy
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 80 (1.25%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 80 (1.25%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 80 (1.25%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 107 (0.00%)
    2 / 80 (2.50%)
    1 / 99 (1.01%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 80 (1.25%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 80 (1.25%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 80 (1.25%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 80 (1.25%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 80 (1.25%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral pericarditis
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 80 (1.25%)
    0 / 99 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    PHN [Postherpetic Neuralgia] HIV-AN [Human Immunodeficiency Virus-associated Neuropathy] PNI [Post-Traumatic Nerve Injury] Other type of Peripheral Neuropathic Pain [PNP]
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    77 / 107 (71.96%)
    44 / 80 (55.00%)
    76 / 99 (76.77%)
    17 / 20 (85.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 107 (5.61%)
    1 / 80 (1.25%)
    3 / 99 (3.03%)
    0 / 20 (0.00%)
         occurrences all number
    8
    1
    3
    0
    Surgical and medical procedures
    Haemangioma removal
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    Application site erythema
         subjects affected / exposed
    24 / 107 (22.43%)
    2 / 80 (2.50%)
    19 / 99 (19.19%)
    6 / 20 (30.00%)
         occurrences all number
    42
    3
    42
    10
    Application site pain
         subjects affected / exposed
    46 / 107 (42.99%)
    21 / 80 (26.25%)
    40 / 99 (40.40%)
    5 / 20 (25.00%)
         occurrences all number
    110
    34
    92
    15
    Influenza like illness
         subjects affected / exposed
    1 / 107 (0.93%)
    1 / 80 (1.25%)
    0 / 99 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    0
    1
    Pain
         subjects affected / exposed
    13 / 107 (12.15%)
    6 / 80 (7.50%)
    16 / 99 (16.16%)
    8 / 20 (40.00%)
         occurrences all number
    29
    6
    35
    16
    Psychiatric disorders
    Middle insomnia
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Muscle strain
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Investigations
    Biopsy skin
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 80 (1.25%)
    0 / 99 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    0
    1
    Blood iron decreased
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Weight decreased
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 107 (0.93%)
    4 / 80 (5.00%)
    2 / 99 (2.02%)
    0 / 20 (0.00%)
         occurrences all number
    1
    4
    2
    0
    Nervous system disorders
    Allodynia
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    0
    1
    Burning sensation
         subjects affected / exposed
    11 / 107 (10.28%)
    8 / 80 (10.00%)
    20 / 99 (20.20%)
    6 / 20 (30.00%)
         occurrences all number
    29
    13
    51
    12
    Dizziness
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    0
    1
    Neuralgia
         subjects affected / exposed
    4 / 107 (3.74%)
    1 / 80 (1.25%)
    6 / 99 (6.06%)
    1 / 20 (5.00%)
         occurrences all number
    5
    1
    7
    1
    Paraesthesia
         subjects affected / exposed
    0 / 107 (0.00%)
    2 / 80 (2.50%)
    1 / 99 (1.01%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    2
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    3 / 99 (3.03%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    3
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 107 (0.00%)
    1 / 80 (1.25%)
    0 / 99 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    0
    1
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Nausea
         subjects affected / exposed
    4 / 107 (3.74%)
    1 / 80 (1.25%)
    8 / 99 (8.08%)
    3 / 20 (15.00%)
         occurrences all number
    5
    1
    8
    6
    Vomiting
         subjects affected / exposed
    2 / 107 (1.87%)
    1 / 80 (1.25%)
    2 / 99 (2.02%)
    2 / 20 (10.00%)
         occurrences all number
    3
    1
    2
    3
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    29 / 107 (27.10%)
    1 / 80 (1.25%)
    29 / 99 (29.29%)
    3 / 20 (15.00%)
         occurrences all number
    79
    1
    77
    10
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 107 (2.80%)
    0 / 80 (0.00%)
    3 / 99 (3.03%)
    1 / 20 (5.00%)
         occurrences all number
    3
    0
    4
    1
    Back pain
         subjects affected / exposed
    3 / 107 (2.80%)
    4 / 80 (5.00%)
    2 / 99 (2.02%)
    1 / 20 (5.00%)
         occurrences all number
    3
    4
    2
    2
    Pain in extremity
         subjects affected / exposed
    2 / 107 (1.87%)
    11 / 80 (13.75%)
    5 / 99 (5.05%)
    1 / 20 (5.00%)
         occurrences all number
    2
    19
    7
    1
    Metabolism and nutrition disorders
    Folate deficiency
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 80 (0.00%)
    1 / 99 (1.01%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    1
    1
    Vitamin B12 deficiency
         subjects affected / exposed
    0 / 107 (0.00%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 107 (1.87%)
    0 / 80 (0.00%)
    2 / 99 (2.02%)
    1 / 20 (5.00%)
         occurrences all number
    2
    0
    2
    1
    Influenza
         subjects affected / exposed
    2 / 107 (1.87%)
    0 / 80 (0.00%)
    7 / 99 (7.07%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    8
    0
    Laryngitis
         subjects affected / exposed
    1 / 107 (0.93%)
    0 / 80 (0.00%)
    0 / 99 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 107 (1.87%)
    0 / 80 (0.00%)
    4 / 99 (4.04%)
    1 / 20 (5.00%)
         occurrences all number
    2
    0
    5
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The original study protocol for this study was dated 30 Apr 2010. There were 4 non-substantial amendments to the study protocol, dated 22 Oct 2010, 01 Mar 2011, 02 Dec 2011, and 28 May 2013.
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    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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