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    Clinical Trial Results:
    Phase 2 multicentric open-label study of switch from abacavir/lamivudine fixed dose combination plus nevirapine to abacavir/lamivudine/dolutegravir in virologically suppressed HIV-1 infected adults

    Summary
    EudraCT number
    		 2013-003197-27
    Trial protocol
    		 FR  
    Global end of trial date
    10 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jul 2022
    First version publication date
    29 Jul 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RC13_0230
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02067767
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHU de Nantes
    Sponsor organisation address
    5 allée de l'île Gloriette, Nantes, France, 44000
    Public contact
    Julie LE BARON, CHU de Nantes, 33 0253482835, bp-prom-regl@chu-nantes.fr
    Scientific contact
    Julie LE BARON, CHU de Nantes, 33 0253482835, bp-prom-regl@chu-nantes.fr
    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
    01 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective is to evaluate virologic safety, e.g. maintenance of virologic suppression, after 12 weeks of switch from NVP + ABC/3TC to DTG/ABC/3TC.
    Protection of trial subjects
    Therapy should be discontinued for any of the following reasons: - Subject or Investigator non-compliance - At the request of the subject, Investigator, or Sponsor - Confirmed virologic failure: Plasma HIV-1 RNA > 50 c/mL - Pregnancy (intrauterine) - Creatinine clearance <50 ml/min - Liver toxicity - Grade 4 clinical Adverse Event considered causally related to Investigationnal Product - Abacavir hypersensitivity reaction clinically suspected.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Feb 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 53
    Worldwide total number of subjects
    53
    EEA total number of subjects
    53
    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)
    41
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First patient was recruited the 26/02/2014 and the last patient the 11/12/2014. Patients were recruited at Nantes UH and La Roche sur Yon Hospital.

    Pre-assignment
    Screening details
    		 Inclusion criteria : -Adults ≥ 18 years -HIV-1 infected patient -On nevirapine (400 mg per day) + ABC/3TC FDC for more than 6 months; Nevirapine 400 mg/day being administered as either 1 x 200 mg IR x 2/day or 2 x 200 mg IR qd or 1 x 400 mg XR qd -No history of prior virologic failure on antiretroviral therapy

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

    Arms
    Arm title
    		 Experimental arm
    Arm description
    		 Abacavir/Lamivudine/Dolutegravir Patients switched from their ongoing treatment of ABC/3TC + NVP to ABC/3TC/DTG.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DTG/ABC/3TC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    DTG/ABC/3TC tablets are purple, oval, biconvex tablets debossed with “572Tri3” on one side and plain on the other side. The tablet contains 52.62 mg dolutegravir sodium which is equivalent to 50 mg dolutegravir free acid, 702 mg abacavir sulfate which is equivalent to 600 mg abacavir and 300 mg lamivudine. The tablets are packaged into HDPA bottles with child-resistant closures that include induction seals. The bottles contain a dessicant. Posology: 1 tablet a day during 48 weeks. Patients will have to take the tablet at breakfast until W12, at least. Route of administration: oral

    Number of subjects in period 1
    		Experimental arm
    Started
    53
    Completed
    52
    Not completed
    1
         Adverse event, non-fatal
    1
    Period 2
    Period 2 title
    Ancillary study
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Ancillary group
    Arm description
    		 To further address potential drug-drug interaction, a subgroup of 10 patients (Group 2) had an overlap of 5 days, receiving both NVP-XR and ABC/3TC/DTG, before stopping NVP-XR and continuing solely ABC/3TC/DTG. A 24h pharmacokinetics evaluation of both NVP and DTG was performed in these 10 patients at Day 0 (at steady-state, 5 days after concomitant intake of NVP-XR + ABC/3TC/DTG) and of DTG at Week 2 (14 days after NVP discontinuation). These patients followed the rest of the study like the other group of patients.
    Arm type
    		 Ancillary

    Investigational medicinal product name
    NVP-XR
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Posology: one 400 mg tablet of NVP-XR once daily during 5 days. Route of administration: oral

    Investigational medicinal product name
    DTG/ABC/3TC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    DTG/ABC/3TC tablets are purple, oval, biconvex tablets debossed with “572Tri3” on one side and plain on the other side. The tablet contains 52.62 mg dolutegravir sodium which is equivalent to 50 mg dolutegravir free acid, 702 mg abacavir sulfate which is equivalent to 600 mg abacavir and 300 mg lamivudine. The tablets are packaged into HDPA bottles with child-resistant closures that include induction seals. The bottles contain a dessicant. Posology: 1 tablet a day during 48 weeks. Patients will have to take the tablet at breakfast until W12, at least. Route of administration: oral

    Number of subjects in period 2 [1]
    		Ancillary group
    Started
    10
    Day 5 and week 2 PK
    10
    Completed
    10
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only 10 patients did the ancillary study

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Experimental arm
    Reporting group description
    		 Abacavir/Lamivudine/Dolutegravir Patients switched from their ongoing treatment of ABC/3TC + NVP to ABC/3TC/DTG.

    Reporting group values
    		 Experimental arm Total
    Number of subjects
    		 53 53
    Age categorical
    53 HIV-1 infected adults, on stable ABC/3TC + NVP 200 mg bid or 400 mg qd, and HIV-1 RNA < 50 c/mL were included in the study. 41 patients were between 18 and 64 years and 12 patients were older than 65.
    Units: Subjects
        Adults (18-64 years)
    		 41 41
        From 65-84 years
    		 12 12
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 52.51 (45.75 to 63.36) -
    Gender categorical
    Units: Subjects
        Female
    		 38 38
        Male
    		 15 15
    CDC stage
    Units: Subjects
        Stage A
    		 32 32
        Stage B
    		 12 12
        Stage C
    		 9 9
    Mode of infection
    Units: Subjects
        homosexual/bisexual
    		 26 26
        heterosexual
    		 24 24
        other
    		 3 3
    Age of HIV diagnosis
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 14.04 (10.56 to 18.55) -
    Duration of undetectable viral charge
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 9.64 (6.25 to 12.46) -
    Duration of ABC/3TC + NVP regimen
    Units: year
        median (inter-quartile range (Q1-Q3))
    		 6.03 (4.27 to 6.73) -

    End points

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    End points reporting groups
    Reporting group title
    Experimental arm
    Reporting group description
    		 Abacavir/Lamivudine/Dolutegravir Patients switched from their ongoing treatment of ABC/3TC + NVP to ABC/3TC/DTG.
    Reporting group title
    Ancillary group
    Reporting group description
    		 To further address potential drug-drug interaction, a subgroup of 10 patients (Group 2) had an overlap of 5 days, receiving both NVP-XR and ABC/3TC/DTG, before stopping NVP-XR and continuing solely ABC/3TC/DTG. A 24h pharmacokinetics evaluation of both NVP and DTG was performed in these 10 patients at Day 0 (at steady-state, 5 days after concomitant intake of NVP-XR + ABC/3TC/DTG) and of DTG at Week 2 (14 days after NVP discontinuation). These patients followed the rest of the study like the other group of patients.

    Primary: Percentage of patients with plasma HIV-1 RNA < 50 copies/mL at week 12

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    End point title
    		 Percentage of patients with plasma HIV-1 RNA < 50 copies/mL at week 12 [1]
    End point description
    End point type
    Primary
    End point timeframe
    Week 12
    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: There is no comparison between 2 types of patient
    End point values
    		 Experimental arm
    Number of subjects analysed
    53
    Units: percentage
    number (not applicable)
        Percentage of patients with plasma HIV-1 RNA < 50
    100
    No statistical analyses for this end point

    Secondary: Percentage of patients with Plasma HIV-1 RNA < 50 copies/ml at W24

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    End point title
    		 Percentage of patients with Plasma HIV-1 RNA < 50 copies/ml at W24
    End point description
    End point type
    Secondary
    End point timeframe
    W24
    End point values
    		 Experimental arm
    Number of subjects analysed
    53
    Units: Percentage
    98
    No statistical analyses for this end point

    Secondary: Percentage of patients with Plasma HIV-1 RNA < 50 copies/ml at W48

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    End point title
    		 Percentage of patients with Plasma HIV-1 RNA < 50 copies/ml at W48
    End point description
    End point type
    Secondary
    End point timeframe
    W48
    End point values
    		 Experimental arm
    Number of subjects analysed
    52
    Units: Percentage
    100
    No statistical analyses for this end point

    Secondary: Percentage of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W12

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    End point title
    		 Percentage of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W12
    End point description
    End point type
    Secondary
    End point timeframe
    W12
    End point values
    		 Experimental arm
    Number of subjects analysed
    53
    Units: Percentage
    81
    No statistical analyses for this end point

    Secondary: Number of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W24

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    End point title
    		 Number of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W24
    End point description
    End point type
    Secondary
    End point timeframe
    W24
    End point values
    		 Experimental arm
    Number of subjects analysed
    53
    Units: Number of patients
    77
    No statistical analyses for this end point

    Secondary: Number of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W48

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    End point title
    		 Number of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W48
    End point description
    End point type
    Secondary
    End point timeframe
    W48
    End point values
    		 Experimental arm
    Number of subjects analysed
    52
    Units: Number of patients
    67
    No statistical analyses for this end point

    Secondary: CD4 and CD8 measurements

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    End point title
    		 CD4 and CD8 measurements
    End point description
    End point type
    Secondary
    End point timeframe
    W48
    End point values
    		 Experimental arm
    Number of subjects analysed
    53
    Units: CD/mm3
    median (inter-quartile range (Q1-Q3))
        CD4 at inclusion
    737 (557 to 915)
        CD4 at W12
    735 (586 to 896)
        CD4 at W24
    763 (563.50 to 1017.50)
        CD4 at W48
    741.50 (551.50 to 1009)
        CD8 at inclusion
    730 (565 to 925)
        CD8 at W12
    729 (565 to 934)
        CD8 at W24
    806.5 (577 to 980)
        CD8 at W48
    812.50 (518.50 to 934.50)
    No statistical analyses for this end point

    Secondary: Serum creatinine measurements

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    End point title
    		 Serum creatinine measurements
    End point description
    End point type
    Secondary
    End point timeframe
    W48
    End point values
    		 Experimental arm
    Number of subjects analysed
    53
    Units: µmol/L
    median (inter-quartile range (Q1-Q3))
        creatinine at inclusion
    77 (65 to 83)
        creatinine at W12
    86 (73 to 98)
        creatinine at W24
    86 (76 to 98)
        creatinine at W36
    87 (74 to 97)
        creatinine at W48
    87 (72 to 96)
    No statistical analyses for this end point

    Secondary: Urinary albumine/creatinine ratio measurementS

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    End point title
    		 Urinary albumine/creatinine ratio measurementS
    End point description
    End point type
    Secondary
    End point timeframe
    W48
    End point values
    		 Experimental arm
    Number of subjects analysed
    53
    Units: mg/mmol
    median (inter-quartile range (Q1-Q3))
        Ratio at inclusion
    6.17 (4.55 to 8.33)
        Ratio at W4
    5.31 (4.27 to 8)
        Ratio at W24
    6.14 (4.25 to 8.43)
        Ratio at W48
    5.55 (3.86 to 9.30)
    No statistical analyses for this end point

    Secondary: Fasting lipids measurement

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    End point title
    		 Fasting lipids measurement
    End point description
    End point type
    Secondary
    End point timeframe
    W48
    End point values
    		 Experimental arm
    Number of subjects analysed
    53
    Units: g/L
    median (inter-quartile range (Q1-Q3))
        Triglycerides at inclusion
    0.98 (0.69 to 1.15)
        Triglycerides at W12
    0.89 (0.72 to 1.27)
        Triglycerides W48
    0.91 (0.71 to 1.16)
        Cholesterol at inclusion
    2.27 (2 to 2.48)
        Cholesterol at W12
    1.98 (1.73 to 2.16)
        Cholesterol at W48
    1.94 (1.60 to 2.15)
        HDL at inclusion
    0.69 (0.56 to 0.84)
        HDL at W12
    0.57 (0.47 to 0.71)
        HDL at W48
    0.56 (0.46 to 0.69)
        LDL at inclusion
    1.32 (1.10 to 1.51)
        LDL at W12
    1.10 (0.89 to 1.35)
        LDL at W48
    1.17 (0.89 to 1.33)
    No statistical analyses for this end point

    Secondary: Mean Cmax of nevirapine between W0 and W2

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    End point title
    		 Mean Cmax of nevirapine between W0 and W2
    End point description
    End point type
    Secondary
    End point timeframe
    W2
    End point values
    		 Ancillary group
    Number of subjects analysed
    10
    Units: µg/L
    geometric mean (confidence interval 95%)
        Nevirapine+dolutegravir+abacavir/lamivudine
    4408 (3581 to 5426)
        Dolutegravir+ abacavir+ lamivudine
    4796 (4077 to 5641)
        ratio nevirapine+dolutegravir+abacavir/lamivudine
    0.92 (0.83 to 1.02)
    No statistical analyses for this end point

    Secondary: Evaluation of patient's satisfaction with HIVTSQs and HIVTSQc questionnaires

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    End point title
    		 Evaluation of patient's satisfaction with HIVTSQs and HIVTSQc questionnaires
    End point description
    End point type
    Secondary
    End point timeframe
    W48
    End point values
    		 Experimental arm
    Number of subjects analysed
    53
    Units: Patient's satisfaction
    median (inter-quartile range (Q1-Q3))
        HIVTSQS global score at inclusion
    54 (51 to 58)
        HIVTSQS general satisfaction at inclusion
    28 (26 to 30)
        HIVTSQS lifestyle/ease at inclusion
    27 (24 to 29)
        HIVTSQS global score at W48
    58 (52.50 to 60)
        HIVTSQS general satisfaction at W48
    29 (28 to 30)
        HIVTSQS lifestyle/ease at W48
    29 (26.50 to 30)
        HIVTSQC global score at W12
    24 (13 to 28)
        HIVTSQC general satisfaction at W12
    12 (7 to 14)
        HIVTSQC lifestyle/ease at W12
    12 (7 to 15)
    No statistical analyses for this end point

    Secondary: GFR (MDRD) measurements

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    End point title
    		 GFR (MDRD) measurements
    End point description
    End point type
    Secondary
    End point timeframe
    W48
    End point values
    		 Experimental arm
    Number of subjects analysed
    53
    Units: ml/min
    median (inter-quartile range (Q1-Q3))
        MDRD at inclusion
    95.15 (78.70 to 118.66)
        MDRD at W4
    79.26 (69.52 to 100.88)
        MDRD at W12
    79.94 (67.97 to 95.61)
        MDRD at W24
    76.97 (65.19 to 95.24)
        MDRD at W36
    77.72 (68.24 to 97.62)
        MDRD at W48
    77.92 (66.96 to 92.40)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    overall
    Reporting group description
    		 -

    Serious adverse events
    		 overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 53 (3.77%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Coronary artery insufficiency
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    46 / 53 (86.79%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Vascular disorders
    Haematoma
    Additional description: 1 patient
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    8 / 53 (15.09%)
         occurrences all number
    8
    Chest pain
         subjects affected / exposed
    2 / 53 (3.77%)
         occurrences all number
    2
    Fatigue
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Inflammation
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Influenza like illness
         subjects affected / exposed
    3 / 53 (5.66%)
         occurrences all number
    3
    Reproductive system and breast disorders
    Epididymal disorder
    Additional description: 1 patient
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Menometrorrhagia
    Additional description: 1 patient
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Prostatitis
    Additional description: 1 patient
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
    Additional description: 1 patient
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Epistaxis
    Additional description: 1 patient
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Lung disorder
    Additional description: 1 patient
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Depression
         subjects affected / exposed
    2 / 53 (3.77%)
         occurrences all number
    2
    Insomnia
         subjects affected / exposed
    3 / 53 (5.66%)
         occurrences all number
    3
    Sleep disorder
    Additional description: 2 patients
         subjects affected / exposed
    2 / 53 (3.77%)
         occurrences all number
    2
    Tobacco withdrawal symptoms
    Additional description: 1 patient
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Investigations
    Serum ferritin increased
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Creatinine renal clearance decreased
         subjects affected / exposed
    2 / 53 (3.77%)
         occurrences all number
    2
    Injury, poisoning and procedural complications
    Arthropod sting
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Contusion
         subjects affected / exposed
    2 / 53 (3.77%)
         occurrences all number
    2
    Post traumatic pain
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Tendinitis
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Hand fracture
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Cardiac disorders
    Pericarditis
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Sciatica
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Cervicobrachial syndrome
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    3 / 53 (5.66%)
         occurrences all number
    3
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Eye disorders
    Photopsia
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Eyelid irritation
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 53 (5.66%)
         occurrences all number
    3
    Abdominal pain upper
         subjects affected / exposed
    3 / 53 (5.66%)
         occurrences all number
    3
    Anal pruritus
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Anorectal disorder
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    6 / 53 (11.32%)
         occurrences all number
    6
    Faeces discoloured
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Faeces soft
         subjects affected / exposed
    3 / 53 (5.66%)
         occurrences all number
    3
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 53 (3.77%)
         occurrences all number
    2
    Gingival bleeding
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Haemorrhoids
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    2
    Mouth ulceration
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    4 / 53 (7.55%)
         occurrences all number
    4
    Steatorrhoea
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Tooth disorder
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Hepatobiliary disorders
    Hepatocellular injury
    Additional description: 2 patients
         subjects affected / exposed
    2 / 53 (3.77%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Acne
    Additional description: 1 patient
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Eczema
    Additional description: 1 patient
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Erythema multiforme
    Additional description: 1 patient
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Night sweats
    Additional description: 1 patient
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Rash erythematous
    Additional description: 1 patient
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Seborrhoeic dermatitis
    Additional description: 1 patient
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Renal and urinary disorders
    Renal impairment
    Additional description: 3 patients
         subjects affected / exposed
    3 / 53 (5.66%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 53 (5.66%)
         occurrences all number
    3
    Back pain
         subjects affected / exposed
    6 / 53 (11.32%)
         occurrences all number
    7
    Intervertebral disc disorder
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Muscle haemorrhage
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Muscle spasms
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    3 / 53 (5.66%)
         occurrences all number
    4
    Osteoarthritis
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    2 / 53 (3.77%)
         occurrences all number
    2
    Rotator cuff syndrome
         subjects affected / exposed
    2 / 53 (3.77%)
         occurrences all number
    2
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Torticollis
         subjects affected / exposed
    2 / 53 (3.77%)
         occurrences all number
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 53 (3.77%)
         occurrences all number
    2
    Cystitis
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Ear infection
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Fungal infection
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Furuncle
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Hordeolum
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Laryngitis
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Oral herpes
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Otitis media acute
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Parasitic gastroenteritis
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Pharyngitis
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    5 / 53 (9.43%)
         occurrences all number
    5
    Sinusitis
         subjects affected / exposed
    2 / 53 (3.77%)
         occurrences all number
    2
    Skin infection
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Tonsillitis
         subjects affected / exposed
    3 / 53 (5.66%)
         occurrences all number
    3
    Urinary tract infection
         subjects affected / exposed
    2 / 53 (3.77%)
         occurrences all number
    2
    Viral pharyngitis
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Viral rhinitis
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 53 (3.77%)
         occurrences all number
    2
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 53 (1.89%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Apr 2014
    Criteria for discontinuation of treatment added and investigator's brochure updated

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26271944
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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