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    Clinical Trial Results:
    Efficacy and safety of gabapentin versus placebo to prevent the incidence of PostHerpetic Neuralgia

    Summary
    EudraCT number
    		 2013-000521-31
    Trial protocol
    		 ES  
    Global end of trial date
    16 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Nov 2017
    First version publication date
    26 Nov 2017
    Other versions
    Summary report(s)
    		 Summary of results

    Trial information

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    Trial identification
    Sponsor protocol code
    PI12_01813
    Additional study identifiers
    ISRCTN number
    		 ISRCTN79871784
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gerencia de Atención Primaria Mallorca
    Sponsor organisation address
    C/ Reina Esclaramunda 9, Palma, Spain, 07005
    Public contact
    Dr. Joan Llobera Canavés, Research Unit/ Gerencia de Atención Primaria Mallorca, 0034 971175883, jllobera@ibsalut.caib.es
    Scientific contact
    Dr. Joan Llobera Canavés, Research Unit/ Gerencia de Atención Primaria Mallorca, 0034 971175883, jllobera@ibsalut.caib.es
    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
    04 May 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of optimal doses of gabapentin for 5 weeks in the acute phase of herpes zoster in patients>= 50 years with moderate to severe pain added to the usual treatment to reduce the percentage of patients without post-herpetic neuralgia at 12 weeks.
    Protection of trial subjects
    This study followed the principles outlined in the Declaration of Helsinki. All patients provided written informed consent, and were told that participation is voluntary and can be withdrawn at any time without any negative consequences concerning their current or future medical treatments. All participants received specific treatment for Herpes related pain, investigator were asked to follow the WHO three-step pain relief ladder : non-opioids (paracetamol); then, as necessary, mild opioids (codeine); then strong opioids such as morphine, until the patient is free of pain. Use of systemic corticosteroids and tricyclic antidepressants will not be allowed.
    Background therapy
    		 All participants were treated with 1000-mg caplets of valacyclovir hydrochloride 3 times a day for 7 days for Herpes Zoster treatment and all participants received specific treatment for Herpes related pain, investigator were asked to follow the WHO three-step pain relief ladder : non-opioids (paracetamol); then, as necessary, mild opioids (codeine); then strong opioids such as morphine, until the patient is free of pain. Use of systemic corticosteroids and tricyclic antidepressants will not be allowed.
    Evidence for comparator
    		 N/A (placebo was the comparator)
    Actual start date of recruitment
    14 Feb 2014
    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
    Spain: 98
    Worldwide total number of subjects
    98
    EEA total number of subjects
    98
    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)
    49
    From 65 to 84 years
    45
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 all patients were recruited between 14/02/2014 to 16/09/2016 from 18 primary care health center in Mallorca

    Pre-assignment
    Screening details
    		 N/A

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    The Hospital Son Espases central pharmacy packaged the study treatments (placebo or gabapentin) using an unblinded randomization code list. The link between the randomization code and the corresponding treatment remained blinded for all other study team members. During the process of randomization, each subject were assigned a randomization code, and given the treatment package with that code. This sequential randomization were generated in blocks of 6.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Gabapentin
    Arm description
    		 Gabapentin were initiated at 300 mg/day and then increased in a stepwise manner according to the instructions for use. The dose weree increased, regardless of whether efficacy is achieved at a lower dose, to a ceiling daily dose of 1800 mg/day. In patients who develop intolerable adverse effects, the dose were reduced. The optimal dose established during the titration period was maintained throughout the remainder of the study and followed by 1 week of dose tapering
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gabapentin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Gabapentin were initiated at 300 mg/day and then increased in a stepwise manner according to the instructions for use. The dose were increased, regardless of whether efficacy is achieved at a lower dose, to a ceiling daily dose of 1800 mg/day. In patients who develop intolerable adverse effects, the dose were reduced. The optimal dose established during the titration period were maintained throughout the remainder of the study and followed by 1 week of dose tapering

    Arm title
    		 placebo
    Arm description
    		 Placebo arm
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    placebo initiated at 300 mg/day and then increased in a stepwise manner according to the instructions for use. The dose were increased, regardless of whether efficacy is achieved at a lower dose, to a ceiling daily dose of 1800 mg/day. In patients who develop intolerable adverse effects, the dose were reduced. The optimal dose established during the titration period were maintained throughout the remainder of the study and followed by 1 week of dose tapering

    Number of subjects in period 1
    		Gabapentin placebo
    Started
    50
    48
    Completed
    33
    42
    Not completed
    17
    6
         Consent withdrawn by subject
    3
    1
         Adverse event, non-fatal
    3
    -
         Lost to follow-up
    10
    5
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Gabapentin
    Reporting group description
    		 Gabapentin were initiated at 300 mg/day and then increased in a stepwise manner according to the instructions for use. The dose weree increased, regardless of whether efficacy is achieved at a lower dose, to a ceiling daily dose of 1800 mg/day. In patients who develop intolerable adverse effects, the dose were reduced. The optimal dose established during the titration period was maintained throughout the remainder of the study and followed by 1 week of dose tapering

    Reporting group title
    placebo
    Reporting group description
    		 Placebo arm

    Reporting group values
    		 Gabapentin placebo Total
    Number of subjects
    		 50 48 98
    Age categorical
    Units: Subjects
        50-64
    		 24 23 47
        65-84
    		 20 23 43
        more than 85
    		 3 1 4
        Not recorded
    		 3 1 4
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.1 ± 11.4 66 ± 11.1 -
    Gender categorical
    Units: Subjects
        Female
    		 27 29 56
        Male
    		 20 18 38
        Not recorded
    		 3 1 4
    Herpes Zoster location
    Units: Subjects
        Torax
    		 26 18 44
        Abdominal
    		 5 5 10
        extremities
    		 8 12 20
        Others
    		 10 13 23
        Not recorded
    		 1 0 1
    Herpes Zoster vacination
    Units: Subjects
        yes
    		 9 10 19
        no
    		 28 31 59
        Not recorded
    		 13 7 20
    Body Mass index
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 28.1 ± 4.7 27.3 ± 5.7 -
    MOS-Sleep (Disturbance)
    Units: N/A
        arithmetic mean (standard deviation)
    		 34.2 ± 25.8 36.6 ± 31.4 -
    MOS-Sleep (snoring)
    Units: n/a
        arithmetic mean (standard deviation)
    		 56.9 ± 37.2 44.9 ± 37.9 -
    MOS-Sleep (short of breath or headache)
    Units: n/a
        arithmetic mean (standard deviation)
    		 10.9 ± 20.1 6.1 ± 15.1 -
    MOS-Sleep(adequacy)
    Units: n/a
        arithmetic mean (standard deviation)
    		 70.4 ± 31.6 70.6 ± 30.7 -
    MOS-Sleep (somnolence)
    Units: n/a
        arithmetic mean (standard deviation)
    		 30.4 ± 19.7 31.6 ± 22 -
    MOS-Sleep (sleep problems index 6)
    Units: n/a
        arithmetic mean (standard deviation)
    		 24.6 ± 18.3 25.2 ± 23.3 -
    MOS-Sleep (sleep problems index 9)
    Units: n/a
        arithmetic mean (standard deviation)
    		 27.4 ± 18.6 28 ± 23.3 -
    Short form Health survey-12 (role Physical)
    Units: n/a
        arithmetic mean (standard deviation)
    		 31.7 ± 9.1 32.6 ± 9 -
    Short form Health survey-12 (Physical functioning)
    Units: n/a
        arithmetic mean (standard deviation)
    		 49.8 ± 10.8 51.3 ± 9.5 -
    Short form Health survey-12 (bodily pain)
    Units: n/a
        arithmetic mean (standard deviation)
    		 30.3 ± 3.8 30.4 ± 3.7 -
    Short form Health survey-12 (General health)
    Units: n/a
        arithmetic mean (standard deviation)
    		 44.5 ± 9.3 45.8 ± 9.9 -
    Short form Health survey-12 (role emotional)
    Units: n/a
        arithmetic mean (standard deviation)
    		 40 ± 9.6 42.5 ± 6.8 -
    Short form Health survey-12(Mental Health)
    Units: n/a
        arithmetic mean (standard deviation)
    		 43.8 ± 2.7 43.4 ± 2.1 -
    Visual Analogue Scale (VAS) pain balseline
    Units: N/A
        arithmetic mean (standard deviation)
    		 67.9 ± 20.2 66.2 ± 18.9 -

    End points

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    End points reporting groups
    Reporting group title
    Gabapentin
    Reporting group description
    		 Gabapentin were initiated at 300 mg/day and then increased in a stepwise manner according to the instructions for use. The dose weree increased, regardless of whether efficacy is achieved at a lower dose, to a ceiling daily dose of 1800 mg/day. In patients who develop intolerable adverse effects, the dose were reduced. The optimal dose established during the titration period was maintained throughout the remainder of the study and followed by 1 week of dose tapering

    Reporting group title
    placebo
    Reporting group description
    		 Placebo arm

    Primary: Post-Herpetic neuralgia (VAS >1) at 12 weeks

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    End point title
    		 Post-Herpetic neuralgia (VAS >1) at 12 weeks
    End point description
    Post herpetic neuralgia defined as at least 10 mm in a Visual Analogue Scale of 100 mm for pain at 12 weeks from inclusion
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 Gabapentin placebo
    Number of subjects analysed
    33
    42
    Units: mm
        post-herpetic neuralgia Yes
    5
    2
    Statistical analysis title
    		 Primary endpoint
    Comparison groups
    Gabapentin v placebo
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05 [1]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 19.7
    Notes
    [1] - P-value =0.144

    Secondary: 50 % Pain reduction at 12 weeks

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    End point title
    		 50 % Pain reduction at 12 weeks
    End point description
    Pain reduction of at least 50% from baseline
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Gabapentin placebo
    Number of subjects analysed
    33
    42
    Units: percentage
        50% Pain reduction-Yes
    30
    42
    Statistical analysis title
    		 Secondaru Outcomes/50% Pain reduction at 12 weeks
    Comparison groups
    Gabapentin v placebo
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≥ 0.05 [2]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 7.72
    Notes
    [2] - P-value=0.046

    Secondary: Quality of life-SF12-General Health Physical

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    End point title
    		 Quality of life-SF12-General Health Physical
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Gabapentin placebo
    Number of subjects analysed
    24
    28
    Units: Sf-12
        arithmetic mean (standard deviation)
    52.6 ± 7.2
    48.4 ± 7.2
    Statistical analysis title
    		 Secondary analysis: Sf-12 General Health
    Comparison groups
    placebo v Gabapentin
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≥ 0.05 [3]
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.72
         upper limit
    		 -1.52
    Notes
    [3] - P-Value=0,093

    Secondary: Dolor Neuropatique Questionnaire-4

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    End point title
    		 Dolor Neuropatique Questionnaire-4
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Gabapentin placebo
    Number of subjects analysed
    32
    37
    Units: Percentage
        DN-4 +
    4
    4
    Statistical analysis title
    		 Secondary analysis:DN-4
    Comparison groups
    Gabapentin v placebo
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≥ 0.05 [4]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.27
         upper limit
    		 5.14
    Notes
    [4] - p-value=0.827

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 weeks
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Gabapentine
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Gabapentine Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 50 (4.00%)
    0 / 48 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Lacunar stroke
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trifascicular block
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Gabapentine Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 50 (22.00%)
    6 / 48 (12.50%)
    General disorders and administration site conditions
    Dizziness
         subjects affected / exposed
    5 / 50 (10.00%)
    3 / 48 (6.25%)
         occurrences all number
    5
    3
    Somnolence
         subjects affected / exposed
    3 / 50 (6.00%)
    2 / 48 (4.17%)
         occurrences all number
    33
    42
    Abdominal pain/vomits
         subjects affected / exposed
    3 / 50 (6.00%)
    1 / 48 (2.08%)
         occurrences all number
    3
    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.
    None reported
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