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    Clinical Trial Results:
    A Phase I, Open-Label Trial to Investigate Pharmacokinetics, Safety and Tolerability of TMC125 at Steady-State in Treatment-Experienced HIV-1 Infected Children

    Summary
    EudraCT number
    		 2006-002183-26
    Trial protocol
    		 DE   GB  
    Global end of trial date
    27 Feb 2008

    Results information
    Results version number
    		 v2(current)
    This version publication date
    23 Jun 2016
    First version publication date
    12 Jun 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Review of data

    Trial information

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    Trial identification
    Sponsor protocol code
    TMC125-C126
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Tibotec Pharmaceuticals Ltd
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, 2340
    Public contact
    Clinical Registry Group, Tibotec Pharmaceuticals Ltd, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Tibotec Pharmaceuticals Ltd, ClinicalTrialsEU@its.jnj.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Feb 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Feb 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Feb 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to obtain steady-state pharmacokinetics of TMC125 in treatment-experienced human immunodeficiency virus - type 1 (HIV-1) infected children and dose recommendations of TMC125 per body weight in treatment-experienced HIV-1 infected children greater than or equal to (>=) 6 years old and weighing >= 20 kilogram (kg).
    Protection of trial subjects
    An interim analysis of the pharmacokinetic and safety data of Stage 1 was performed in order to decide whether or not to proceed to Stage 2 of the trial. The safety assessments included laboratory measurements (for example biochemistry, blood coagulation, hematology, and urinalysis), cardiovascular safety, vital sign measurements and electrocardiograms (ECGs). Adverse events and vital signs were monitored throughout the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Sep 2006
    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
    Germany: 20
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    Italy: 11
    Country: Number of subjects enrolled
    United States: 1
    Worldwide total number of subjects
    42
    EEA total number of subjects
    41
    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)
    22
    Adolescents (12-17 years)
    20
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In total 42 participants enrolled into the study of whom 35 are unique participants and 7 have participated in both stage 1 and 2.

    Pre-assignment
    Screening details
    		 A total of 42 participants were enrolled and treated with etravirine also known as TMC125 and included in the intent-to-treat (ITT) population.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Stage I: 6-11 Years Old
    Arm description
    		 Participants of 6-11 years old received 4 milligram per kilogram (mg/kg) of TMC125 twice daily for 7 days with an additional morning dose on Day 8.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TMC125
    Investigational medicinal product code
    TMC125 (Formulation - F060 and F066)
    Other name
    R165335, Lab code 094268
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants of 6-11 years old received 4 milligram per kilogram (mg/kg) of TMC125 twice daily for 7 days with an additional morning dose on Day 8.

    Arm title
    		 Stage I: 12-17 Years Old
    Arm description
    		 Participants of 12-17 years old received 4 milligram per kilogram (mg/kg) of TMC125 twice daily for 7 days with an additional morning dose on Day 8.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TMC125
    Investigational medicinal product code
    TMC125 (Formulation - F060 and F066)
    Other name
    R165335, Lab code 094268
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants of 12-17 years old received 4 milligram per kilogram (mg/kg) of TMC125 twice daily for 7 days with an additional morning dose on Day 8.

    Arm title
    		 Stage II: 6-11 Years Old
    Arm description
    		 Participants of 6-11 years old received 5.2 milligram per kilogram (mg/kg) of TMC125 twice daily for 7 days with an additional morning dose on Day 8.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TMC125
    Investigational medicinal product code
    TMC125 (Formulation - F060 and F066)
    Other name
    R165335, Lab code 094268
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants of 6-11 years old received 5.2 milligram per kilogram (mg/kg) of TMC125 twice daily for 7 days with an additional morning dose on Day 8.

    Arm title
    		 Stage II: 12-17 Years Old
    Arm description
    		 Participants of 12-17 years old received 5.2 milligram per kilogram (mg/kg) of TMC125 twice daily for 7 days with an additional morning dose on Day 8.
    Arm type
    		 Experimental

    Investigational medicinal product name
    TMC125
    Investigational medicinal product code
    TMC125 (Formulation - F060 and F066)
    Other name
    R165335, Lab code 094268
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants of 12-17 years old received 5.2 milligram per kilogram (mg/kg) of TMC125 twice daily for 7 days with an additional morning dose on Day 8.

    Number of subjects in period 1
    		Stage I: 6-11 Years Old Stage I: 12-17 Years Old Stage II: 6-11 Years Old Stage II: 12-17 Years Old
    Started
    10
    11
    12
    9
    Completed
    10
    10
    12
    9
    Not completed
    0
    1
    0
    0
         Adverse Event
    -
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Stage I: 6-11 Years Old
    Reporting group description
    		 Participants of 6-11 years old received 4 milligram per kilogram (mg/kg) of TMC125 twice daily for 7 days with an additional morning dose on Day 8.

    Reporting group title
    Stage I: 12-17 Years Old
    Reporting group description
    		 Participants of 12-17 years old received 4 milligram per kilogram (mg/kg) of TMC125 twice daily for 7 days with an additional morning dose on Day 8.

    Reporting group title
    Stage II: 6-11 Years Old
    Reporting group description
    		 Participants of 6-11 years old received 5.2 milligram per kilogram (mg/kg) of TMC125 twice daily for 7 days with an additional morning dose on Day 8.

    Reporting group title
    Stage II: 12-17 Years Old
    Reporting group description
    		 Participants of 12-17 years old received 5.2 milligram per kilogram (mg/kg) of TMC125 twice daily for 7 days with an additional morning dose on Day 8.

    Reporting group values
    		 Stage I: 6-11 Years Old Stage I: 12-17 Years Old Stage II: 6-11 Years Old Stage II: 12-17 Years Old Total
    Number of subjects
    		 10 11 12 9 42
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 10 0 12 0 22
        Adolescents (12-17 years)
    		 0 11 0 9 20
        Adults (18-64 years)
    		 0 0 0 0 0
        From 65 to 84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 8.6 ( 1.35 ) 13.7 ( 1.49 ) 14.4 ( 1.74 ) 9.2 ( 1.27 ) -
    Title for Gender
    Units: subjects
        Female
    		 4 4 8 5 21
        Male
    		 6 7 4 4 21

    End points

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    End points reporting groups
    Reporting group title
    Stage I: 6-11 Years Old
    Reporting group description
    		 Participants of 6-11 years old received 4 milligram per kilogram (mg/kg) of TMC125 twice daily for 7 days with an additional morning dose on Day 8.

    Reporting group title
    Stage I: 12-17 Years Old
    Reporting group description
    		 Participants of 12-17 years old received 4 milligram per kilogram (mg/kg) of TMC125 twice daily for 7 days with an additional morning dose on Day 8.

    Reporting group title
    Stage II: 6-11 Years Old
    Reporting group description
    		 Participants of 6-11 years old received 5.2 milligram per kilogram (mg/kg) of TMC125 twice daily for 7 days with an additional morning dose on Day 8.

    Reporting group title
    Stage II: 12-17 Years Old
    Reporting group description
    		 Participants of 12-17 years old received 5.2 milligram per kilogram (mg/kg) of TMC125 twice daily for 7 days with an additional morning dose on Day 8.

    Subject analysis set title
    Intent-to-treat (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intent-to-treat (ITT) population include those participants who had received at least 1 dose of study medication.

    Primary: Minimum Plasma Concentration (Cmin) of TMC125

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    End point title
    		 Minimum Plasma Concentration (Cmin) of TMC125 [1]
    End point description
    The Cmin is the minimum observed plasma concentration of TMC125.
    End point type
    Primary
    End point timeframe
    Pre-dose; 0, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 8
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Stage I: 6-11 Years Old Stage I: 12-17 Years Old Stage II: 6-11 Years Old Stage II: 12-17 Years Old
    Number of subjects analysed
    9
    10
    11
    9
    Units: nanogram per milliliter (ng/mL)
        arithmetic mean (standard deviation)
    208.6 ( 210.1 )
    160.8 ( 70.16 )
    362.8 ( 351.7 )
    210.5 ( 119.8 )
    No statistical analyses for this end point

    Primary: Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC[0-12]) Post Dose of TMC125

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    End point title
    		 Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours (AUC[0-12]) Post Dose of TMC125 [2]
    End point description
    The AUC (0-12hrs) is the area under the plasma TMC125 concentration-time curve from 0 to 12 hours post dosing.
    End point type
    Primary
    End point timeframe
    Pre-dose; 0, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 8
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Stage I: 6-11 Years Old Stage I: 12-17 Years Old Stage II: 6-11 Years Old Stage II: 12-17 Years Old
    Number of subjects analysed
    8
    10
    11
    9
    Units: ng.h/mL
        arithmetic mean (standard deviation)
    4989 ( 5189 )
    3299 ( 1468 )
    7713 ( 7160 )
    4219 ( 1575 )
    No statistical analyses for this end point

    Secondary: Predose Plasma Concentration (C0h) of TMC125

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    End point title
    		 Predose Plasma Concentration (C0h) of TMC125
    End point description
    The C0h is the predose plasma observed concentration of TMC125.
    End point type
    Secondary
    End point timeframe
    Predose on Day 8
    End point values
    		 Stage I: 6-11 Years Old Stage I: 12-17 Years Old Stage II: 6-11 Years Old Stage II: 12-17 Years Old
    Number of subjects analysed
    9
    10
    11
    9
    Units: nanogram per milliliter (ng/mL)
        arithmetic mean (standard deviation)
    238.1 ( 202.4 )
    178 ( 63.23 )
    453.3 ( 441.6 )
    246.7 ( 154.6 )
    No statistical analyses for this end point

    Secondary: Maximum Plasma Concentration (Cmax) of TMC125

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    End point title
    		 Maximum Plasma Concentration (Cmax) of TMC125
    End point description
    The Cmax is the maximum observed plasma concentration of TMC125.
    End point type
    Secondary
    End point timeframe
    Pre-dose; 0, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 8
    End point values
    		 Stage I: 6-11 Years Old Stage I: 12-17 Years Old Stage II: 6-11 Years Old Stage II: 12-17 Years Old
    Number of subjects analysed
    9
    10
    11
    9
    Units: nanogram per milliliter (ng/mL)
        arithmetic mean (standard deviation)
    597.9 ( 634.8 )
    402.9 ( 180.5 )
    971.1 ( 866.4 )
    494.3 ( 144 )
    No statistical analyses for this end point

    Secondary: Time to Reach the Maximum Plasma Concentration (Tmax) of TMC125

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    End point title
    		 Time to Reach the Maximum Plasma Concentration (Tmax) of TMC125
    End point description
    The Tmax is the time to reach the maximum observed plasma concentration of TMC125.
    End point type
    Secondary
    End point timeframe
    Pre-dose; 0, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 8
    End point values
    		 Stage I: 6-11 Years Old Stage I: 12-17 Years Old Stage II: 6-11 Years Old Stage II: 12-17 Years Old
    Number of subjects analysed
    9
    10
    11
    9
    Units: Hour (h)
        median (full range (min-max))
    4.02 (2.83 to 8)
    4 (2 to 6.02)
    4 (2 to 6.07)
    3.92 (2.98 to 6)
    No statistical analyses for this end point

    Secondary: Average Steady-State Plasma Concentration (Css,av) of TMC125

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    End point title
    		 Average Steady-State Plasma Concentration (Css,av) of TMC125
    End point description
    The Css,av is calculated by area under the plasma concentration-time curve (AUC) x dosing interval/dosing interval at steady-state (AUCτ / τ), where τ = dosing interval.
    End point type
    Secondary
    End point timeframe
    Pre-dose; 0, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 8
    End point values
    		 Stage I: 6-11 Years Old Stage I: 12-17 Years Old Stage II: 6-11 Years Old Stage II: 12-17 Years Old
    Number of subjects analysed
    8
    10
    11
    9
    Units: nanogram per milliliter (ng/mL)
        arithmetic mean (standard deviation)
    416.3 ( 431.3 )
    275.8 ( 121.8 )
    644.3 ( 595.7 )
    352.6 ( 132.6 )
    No statistical analyses for this end point

    Secondary: Fluctuation Index (Fl Ind) of TMC125

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    End point title
    		 Fluctuation Index (Fl Ind) of TMC125
    End point description
    The Fl Ind is defined as percentage fluctuation is variation between maximum and minimum plasma concentration at steady-state, calculated as 100 x ([Cmax-Cmin]/Css,av).
    End point type
    Secondary
    End point timeframe
    Pre-dose; 0, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 8
    End point values
    		 Stage I: 6-11 Years Old Stage I: 12-17 Years Old Stage II: 6-11 Years Old Stage II: 12-17 Years Old
    Number of subjects analysed
    8
    10
    11
    9
    Units: Percentage (%)
        arithmetic mean (standard deviation)
    107.9 ( 44.09 )
    87.97 ( 13.23 )
    102.9 ( 24.98 )
    86.79 ( 26.75 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening up to Follow-up (1 month after last dose administration)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.1
    Reporting groups
    Reporting group title
    Stage I: 6-11 years old
    Reporting group description
    		 Stage I Subjects 6-11 years old received 4 mg/kg of TMC125 twice daily for 7 days with an additional morning dose on Day 8

    Reporting group title
    Stage I: 12-17 years old
    Reporting group description
    		 Participants of 12-17 years old received 4 milligram per kilogram (mg/kg) of TMC125 twice daily for 7 days with an additional morning dose on Day 8.

    Reporting group title
    Stage II: 6-11 years old
    Reporting group description
    		 Participants of 6-11 years old received 5.2 milligram per kilogram (mg/kg) of TMC125 twice daily for 7 days with an additional morning dose on Day 8.

    Reporting group title
    Stage II: 12-17 years old
    Reporting group description
    		 Participants of 12-17 years old received 5.2 milligram per kilogram (mg/kg) of TMC125 twice daily for 7 days with an additional morning dose on Day 8.

    Serious adverse events
    		 Stage I: 6-11 years old Stage I: 12-17 years old Stage II: 6-11 years old Stage II: 12-17 years old
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 9 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Stage I: 6-11 years old Stage I: 12-17 years old Stage II: 6-11 years old Stage II: 12-17 years old
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 10 (70.00%)
    7 / 11 (63.64%)
    3 / 12 (25.00%)
    6 / 9 (66.67%)
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood triglycerides increased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Excoriation
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Traumatic haematoma
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    Headache
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 11 (18.18%)
    0 / 12 (0.00%)
    3 / 9 (33.33%)
         occurrences all number
    1
    2
    0
    4
    Syncope vasovagal
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    Nausea
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    1 / 12 (8.33%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pharyngeal erythema
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pharyngolaryngeal pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rash maculo-papular
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rash
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Psychiatric disorders
    Abnormal dreams
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    1 / 12 (8.33%)
    1 / 9 (11.11%)
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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Aug 2006
    The overall reason for the amendment was to delete baseline urine alcohol and drug test and to remove the requirement for automated device for blood pressure and pulse rate measurements.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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