Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    An Open Label, Parallel Group, Multi-centre, Phase III Study to Assess the Efficacy and Safety of D961H for the Maintenance Therapy Following Initial Treatment in Japanese Paediatric Patients with Reflux Esophagitis and for the Prevention of Recurrence of Gastric Ulcer or Duodenal Ulcer in Japanese Paediatric Patients Treated with Non-steroidal Anti-inflammatory Drugs or Low-dose Aspirin

    Summary
    EudraCT number
    		 2018-000213-20
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    10 May 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jul 2023
    First version publication date
    07 Jul 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D961WC00001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Biometrics & Real World Analytics Department, AstraZeneca Japan
    Sponsor organisation address
    Grand Front Osaka Tower B. 3-1, Ofuka-cho, Kita-ku, Osaka, Japan, 530-0011
    Public contact
    Masahiro Nii/Japan project statistician, Biometrics & Real World Analytics Department, AstraZeneca Japan, 81 7022748322, masahiro.nii@astrazeneca.com
    Scientific contact
    Masahiro Nii/Japan project statistician, Biometrics & Real World Analytics Department, AstraZeneca Japan, 81 7022748322, masahiro.nii@astrazeneca.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
    10 Apr 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Apr 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    10 May 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    There were two primary objectives in this study. One of the primary objectives was to assess the efficacy and safety of once-daily oral administration of D961H for the maintenance of RE healing in Japanese paediatric patients aged 1 to 14 years that have symptomatically healed RE (defined as no more than mild RE-related symptoms) and if EGD is done, no visible mucosal breaks observed. The other was to assess the efficacy and safety of once-daily oral administration of D961H for the prevention of GU/DU recurrence in Japanese paediatric patients aged 1 to 14 years treated with long term NSAIDs/LDA therapy.
    Protection of trial subjects
    Nothing special
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Jul 2018
    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
    Japan: 49
    Worldwide total number of subjects
    49
    EEA total number of subjects
    0
    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)
    10
    Children (2-11 years)
    26
    Adolescents (12-17 years)
    13
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 First subject enrolled on 24 July 2018 Last subject last visit on 27 December 2022. This study was conducted at a total of 17 sites in Japan.

    Pre-assignment
    Screening details
    		 Out of 53 enrolled subjects, 49 subjects were registered and 4 subjects were not registered. The reasons of no registration were 'Screening Failure at screening visit" (3 subjects) and "Prematurely discontinued initial healing therapy period" (1 subject in Group 2).

    Pre-assignment period milestones
    Number of subjects started
    		 49
    Number of subjects completed
    		 49

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This study was open.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily, Body weight<20 kg
    Arm type
    		 Experimental

    Investigational medicinal product name
    D961H
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard, Granules for oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg once daily

    Arm title
    		 Group 2
    Arm description
    		 Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 20 mg once-daily; Maintenance phase (24 or 44 weeks) starts with D961H 10 mg once-daily and may be increased to 20 mg once-daily based on investigator's discretion, Body weight>=20 kg
    Arm type
    		 Experimental

    Investigational medicinal product name
    D961H
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard, Granules for oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg or 20 mg once daily

    Arm title
    		 Group 3
    Arm description
    		 Prevention of recurrence for gastric ulcer and/or duodenal ulcer, D961H 10 mg once-daily (32 or 52 weeks), Body weight<20 kg
    Arm type
    		 Experimental

    Investigational medicinal product name
    D961H
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard, Granules for oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg once daily

    Arm title
    		 Group 4
    Arm description
    		 Prevention of recurrence for gastric and/or duodenal ulcer, D961H starts with 10 mg once-daily, and may be increased to 20 mg once-daily based on investigator's discretion (32 or 52 weeks), Body weight>=20 kg
    Arm type
    		 Experimental

    Investigational medicinal product name
    D961H
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard, Granules for oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg or 20 mg once daily

    Number of subjects in period 1
    		Group 1 Group 2 Group 3 Group 4
    Started
    7
    20
    9
    13
    Completed
    6
    18
    9
    12
    Not completed
    1
    2
    0
    1
         Physician decision
    1
    1
    -
    -
         Consent withdrawn by subject
    -
    -
    -
    1
         Protocol deviation
    -
    1
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily, Body weight<20 kg

    Reporting group title
    Group 2
    Reporting group description
    		 Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 20 mg once-daily; Maintenance phase (24 or 44 weeks) starts with D961H 10 mg once-daily and may be increased to 20 mg once-daily based on investigator's discretion, Body weight>=20 kg

    Reporting group title
    Group 3
    Reporting group description
    		 Prevention of recurrence for gastric ulcer and/or duodenal ulcer, D961H 10 mg once-daily (32 or 52 weeks), Body weight<20 kg

    Reporting group title
    Group 4
    Reporting group description
    		 Prevention of recurrence for gastric and/or duodenal ulcer, D961H starts with 10 mg once-daily, and may be increased to 20 mg once-daily based on investigator's discretion (32 or 52 weeks), Body weight>=20 kg

    Reporting group values
    		 Group 1 Group 2 Group 3 Group 4 Total
    Number of subjects
    		 7 20 9 13 49
    Age Categorical
    Units: Participants
        <=3 years
    		 4 0 2 0 6
        4-5 years
    		 1 0 3 0 4
        6-7 years
    		 2 2 3 1 8
        8-9 years
    		 0 7 1 1 9
        10-11 years
    		 0 4 0 5 9
        12-14 years
    		 0 7 0 6 13
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 3.7 ± 1.7 10.4 ± 2.2 5.2 ± 2.1 11.3 ± 2.4 -
    Sex: Female, Male
    Units: Participants
        Female
    		 0 6 5 7 18
        Male
    		 7 14 4 6 31
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 7 20 9 13 49
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 0 0 0 0 0
        White
    		 0 0 0 0 0
        More than one race
    		 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0 0

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily, Body weight<20 kg

    Reporting group title
    Group 2
    Reporting group description
    		 Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 20 mg once-daily; Maintenance phase (24 or 44 weeks) starts with D961H 10 mg once-daily and may be increased to 20 mg once-daily based on investigator's discretion, Body weight>=20 kg

    Reporting group title
    Group 3
    Reporting group description
    		 Prevention of recurrence for gastric ulcer and/or duodenal ulcer, D961H 10 mg once-daily (32 or 52 weeks), Body weight<20 kg

    Reporting group title
    Group 4
    Reporting group description
    		 Prevention of recurrence for gastric and/or duodenal ulcer, D961H starts with 10 mg once-daily, and may be increased to 20 mg once-daily based on investigator's discretion (32 or 52 weeks), Body weight>=20 kg

    Primary: Presence/absence of reflux esophagitis relapse from Week 8 to Week 32

    		 Close Top of page
    End point title
    		 Presence/absence of reflux esophagitis relapse from Week 8 to Week 32 [1] [2]
    End point description
    Maintenance therapy for healed reflux esophagitis study part: Presence/absence of reflux esophagitis relapse from 8 to 32 weeks for all participants by assessment of the composite endpoint (reflux esophagitis -related symptoms or optional esophagogastroduodenoscopy findings) during the maintenance therapy.
    End point type
    Primary
    End point timeframe
    8 to 32 weeks
    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 was no plan to compare the endpoint between the arms. The objective of this study was to evaluate the number of participants with presence of reflux esophagitis in each arm.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There was no plan to compare the endpoint between the arms. The objective of this study was to evaluate the number of participants with presence of reflux esophagitis in each arm.
    End point values
    		 Group 1 Group 2
    Number of subjects analysed
    7
    19
    Units: Participants
        Presence of reflux esophagitis relapse
    0
    1
        Absence of reflux esophagitis relapse
    7
    18
    No statistical analyses for this end point

    Primary: Presence/absence of gastric ulcer or duodenal ulcer recurrence from Week 0 to Week 32

    		 Close Top of page
    End point title
    		 Presence/absence of gastric ulcer or duodenal ulcer recurrence from Week 0 to Week 32 [3] [4]
    End point description
    Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part: Presence/absence of gastric ulcer or duodenal ulcer recurrence from 0 to 32 weeks for all participants by assessment of the composite endpoint (gastric ulcer or duodenal ulcer-related symptoms or optional esophagogastroduodenoscopy findings) during the prevention therapy.
    End point type
    Primary
    End point timeframe
    0 to 32 weeks
    Notes
    [3] - 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 was no plan to compare the endpoint between the arms. The objective of this study was to evaluate the number of participants with presence of GU/DU recurrence in each arm.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was applied only for Group 3 and Group 4.
    End point values
    		 Group 3 Group 4
    Number of subjects analysed
    9
    13
    Units: Participants
        Presence of GU or DU recurrence
    1
    0
        Absence of GU or DU recurrence
    8
    13
    No statistical analyses for this end point

    Primary: Adverse events during reflux esophagitis maintenance therapy from Week 8 to Week 32

    		 Close Top of page
    End point title
    		 Adverse events during reflux esophagitis maintenance therapy from Week 8 to Week 32 [5] [6]
    End point description
    Maintenance therapy for healed reflux esophagitis study part: Safety from 8 to 32 weeks for all participants. Number of participants with any adverse event during the period.
    End point type
    Primary
    End point timeframe
    8 to 32 weeks
    Notes
    [5] - 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 was no plan to compare the endpoint between the arms. The objective of this study was to evaluate the number of participants with any adverse events in each arm.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was applied only for Group 1 and Group 2.
    End point values
    		 Group 1 Group 2
    Number of subjects analysed
    7
    20
    Units: Participants
        Participants with any adverse event
    7
    16
    No statistical analyses for this end point

    Primary: Adverse events during gastric ulcer or duodenal ulcer recurrence prevention therapy from Week 0 to Week 32

    		 Close Top of page
    End point title
    		 Adverse events during gastric ulcer or duodenal ulcer recurrence prevention therapy from Week 0 to Week 32 [7] [8]
    End point description
    Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part: Safety from 0 to 32 weeks for all participants. Number of participants with any adverse event during the period.
    End point type
    Primary
    End point timeframe
    0 to 32 weeks
    Notes
    [7] - 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 was no plan to compare the endpoint between the arms. The objective of this study was to evaluate the number of participants with any adverse events in each arm.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was applied only for Group 3 and Group 4.
    End point values
    		 Group 3 Group 4
    Number of subjects analysed
    9
    13
    Units: Participants
        Participants with any adverse event
    8
    11
    No statistical analyses for this end point

    Secondary: Presence/absence of reflux esophagitis relapse from Week 8 to Week 52

    		 Close Top of page
    End point title
    		 Presence/absence of reflux esophagitis relapse from Week 8 to Week 52 [9]
    End point description
    Presence/absence of reflux esophagitis relapse from 8 to 52 weeks for participants who continued the study treatment after Week 32 by assessment of the composite endpoint (reflux esophagitis-related symptoms or optional esophagogastroduodenoscopy findings) during the maintenance therapy.
    End point type
    Secondary
    End point timeframe
    8 to 52 weeks
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was applied only for Group 1 and Group 2.
    End point values
    		 Group 1 Group 2
    Number of subjects analysed
    6
    16
    Units: Participants
        Presence of reflux esophagitis relapse
    1
    4
        Absence of reflux esophagitis relapse
    5
    12
    No statistical analyses for this end point

    Secondary: Presence/absence of gastric ulcer or duodenal ulcer recurrence from Week 0 to Week 52

    		 Close Top of page
    End point title
    		 Presence/absence of gastric ulcer or duodenal ulcer recurrence from Week 0 to Week 52 [10]
    End point description
    Presence/absence of gastric ulcer or duodenal ulcer recurrence from 0 to 52 weeks for participants who continued the study treatment after Week 32 by assessment of the composite endpoint (gastric ulcer or duodenal ulcer-related symptoms or optional esophagogastroduodenoscopy findings) during the prevention therapy.
    End point type
    Secondary
    End point timeframe
    0 to 52 weeks
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was applied only for Group 3 and Group 4.
    End point values
    		 Group 3 Group 4
    Number of subjects analysed
    6
    7
    Units: Participants
        Presence of GU or DU recurrence
    1
    0
        Absence of GU or DU recurrence
    5
    7
    No statistical analyses for this end point

    Secondary: Adverse events during reflux esophagitis maintenance therapy from Week 8 to Week 52

    		 Close Top of page
    End point title
    		 Adverse events during reflux esophagitis maintenance therapy from Week 8 to Week 52 [11]
    End point description
    Maintenance therapy for healed reflux esophagitis study part: Safety from 8 to 52 weeks for participants who continued the study treatment after Week 32. Number of participants with any adverse event during the period
    End point type
    Secondary
    End point timeframe
    8 to 52 weeks
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was applied only for Group 1 and Group 2.
    End point values
    		 Group 1 Group 2
    Number of subjects analysed
    6
    16
    Units: Participants
        Participants with any adverse event
    6
    15
    No statistical analyses for this end point

    Secondary: Adverse events during gastric ulcer or duodenal ulcer recurrence prevention therapy from Week 0 to Week 52

    		 Close Top of page
    End point title
    		 Adverse events during gastric ulcer or duodenal ulcer recurrence prevention therapy from Week 0 to Week 52 [12]
    End point description
    Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part: Safety from 0 to 52 weeks for participants who continued the study treatment after Week 32. Number of participants with any adverse event
    End point type
    Secondary
    End point timeframe
    0 to 52 weeks
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was applied only for Group 3 and Group 4.
    End point values
    		 Group 3 Group 4
    Number of subjects analysed
    6
    7
    Units: Participants
        Participants with any adverse event
    6
    6
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events were collected from the date of signing of informed consent to 52 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 52 weeks or withdrawal.
    Adverse event reporting additional description
    For Group 1 and 2, only adverse events that occurred after the start of the maintenance therapy, that is, Week 8 were summarized. For Group 3 and 4, all adverse events that occurred after the start of the prevention therapy period were summarized.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily, Body weight<20 kg

    Reporting group title
    Group 4
    Reporting group description
    		 Prevention of recurrence for gastric and/or duodenal ulcer, D961H starts with 10 mg once-daily, and may be increased to 20 mg once-daily based on investigator's discretion (32 or 52 weeks), Body weight>=20 kg

    Reporting group title
    Group 3
    Reporting group description
    		 Prevention of recurrence for gastric ulcer and/or duodenal ulcer, D961H 10 mg once-daily (32 or 52 weeks), Body weight<20 kg

    Reporting group title
    Group 2
    Reporting group description
    		 Maintenance of healing for reflux esophagitis, Initial healing phase (8 weeks), D961H 20 mg once-daily; Maintenance phase (24 or 44 weeks) starts with D961H 10 mg once-daily and may be increased to 20 mg once-daily based on investigator's discretion, Body weight>=20 kg

    Serious adverse events
    		 Group 1 Group 4 Group 3 Group 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 13 (15.38%)
    3 / 9 (33.33%)
    1 / 20 (5.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Polyarteritis nodosa
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (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
    Congenital, familial and genetic disorders
    Pulmonary artery atresia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    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
    Cyclic vomiting syndrome
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    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
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (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
    Musculoskeletal and connective tissue disorders
    Chronic recurrent multifocal osteomyelitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    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
    Infections and infestations
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (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: 3%
    Non-serious adverse events
    		 Group 1 Group 4 Group 3 Group 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 7 (100.00%)
    11 / 13 (84.62%)
    9 / 9 (100.00%)
    17 / 20 (85.00%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 13 (0.00%)
    2 / 9 (22.22%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    2
    1
    Peripheral swelling
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    1
    0
    2
    Food allergy
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Drug hypersensitivity
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    13
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Bronchitis chronic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Upper respiratory tract inflammation
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    0
    5
    Rhinitis allergic
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    0
    2
    Oropharyngeal pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Cough
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Agitation
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Restlessness
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Fall
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Heat stroke
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Traumatic haematoma
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Wound
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Spinal compression fracture
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nail injury
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Ligament sprain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    0
    1
    Thermal burn
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Orthostatic intolerance
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    0
    1
    Somnolence
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Headache
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    0
    0
    7
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Neutropenia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear and labyrinth disorders
    Motion sickness
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye disorders
    Accommodation disorder
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Chronic gastritis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    0
    1
    Abdominal distension
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Acetonaemic vomiting
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Enterocolitis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    1
    Dental caries
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Constipation
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    5 / 20 (25.00%)
         occurrences all number
    1
    0
    1
    5
    Colitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Eosinophilic oesophagitis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 13 (7.69%)
    2 / 9 (22.22%)
    2 / 20 (10.00%)
         occurrences all number
    1
    3
    2
    2
    Stomatitis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    1
    0
    2
    Malpositioned teeth
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Acne
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Ingrowing nail
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Miliaria
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    2 / 9 (22.22%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Rash
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    2 / 9 (22.22%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    2
    2
    Dry skin
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Musculoskeletal and connective tissue disorders
    Chronic recurrent multifocal osteomyelitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Back pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Arthralgia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ankylosing spondylitis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    1
    Mixed connective tissue disease
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Osteoporosis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rheumatoid nodule
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    0
    1
    Bronchitis mycoplasmal
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Bronchitis
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
         occurrences all number
    6
    0
    1
    0
    Acute haemorrhagic conjunctivitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cystitis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Herpangina
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Herpes zoster
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dermatitis infected
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Erythema infectiosum
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 13 (0.00%)
    3 / 9 (33.33%)
    5 / 20 (25.00%)
         occurrences all number
    1
    0
    4
    5
    Hand-foot-and-mouth disease
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    6 / 7 (85.71%)
    4 / 13 (30.77%)
    2 / 9 (22.22%)
    5 / 20 (25.00%)
         occurrences all number
    12
    16
    9
    10
    Molluscum contagiosum
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Influenza
         subjects affected / exposed
    2 / 7 (28.57%)
    3 / 13 (23.08%)
    0 / 9 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    2
    3
    0
    2
    Hordeolum
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pneumonia mycoplasmal
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Otitis media acute
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Paronychia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pharyngitis
         subjects affected / exposed
    3 / 7 (42.86%)
    3 / 13 (23.08%)
    2 / 9 (22.22%)
    0 / 20 (0.00%)
         occurrences all number
    6
    3
    6
    0
    Otitis media
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    1
    Skin candida
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Skin bacterial infection
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Sinusitis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    1
    0
    0
    3
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Viral infection
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Varicella
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 13 (7.69%)
    2 / 9 (22.22%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    2
    3
    Tonsillitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Streptococcal infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    2 / 9 (22.22%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    2
    1
    Metabolism and nutrition disorders
    Vitamin K deficiency
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1
    Zinc deficiency
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    1

    More information

    		 Close Top of page

    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.
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Wed May 15 08:09:17 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA