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   43857   clinical trials with a EudraCT protocol, of which   7284   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:
    A randomised, double-blind, double-dummy, parallel-group, multicenter, phase IIb study to evaluate the effect of ticagrelor 10 mg and 45 mg bid versus placebo in reducing the number of days with pain in young adults with sickle cell disease.

    Summary
    EudraCT number
    		 2014-005420-10
    Trial protocol
    		 GB  
    Global end of trial date
    16 Nov 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Oct 2017
    First version publication date
    14 Oct 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D5136C00008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02482298
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    Pepparedsleden 1, S 431 83, Mölndal, Sweden,
    Public contact
    Brilinta Global Clinical Leader, AstraZeneca, +46 31 776 10 00,
    Scientific contact
    Brilinta Global Clinical Leader, AstraZeneca, +46 31 776 10 00,
    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
    09 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Nov 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the efficacy of 2 different doses of ticagrelor versus placebo in reducing the number of days with pain due to sickle cell disease.
    Protection of trial subjects
    A Study Steering Committee (SSC) and an Independent Expert Committee were used for this study. The SSC consisted of 4 active PIs who provided input in order to meet trial objectives. Monthly safety reports were provided in order to be aware of emerging safety results. The Independent Expert Committee consisted of 2 external members responsible for reviewing and commenting on the cumulative safety data.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Jul 2015
    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
    Egypt: 21
    Country: Number of subjects enrolled
    Kenya: 33
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Lebanon: 7
    Country: Number of subjects enrolled
    United States: 6
    Country: Number of subjects enrolled
    Turkey: 13
    Country: Number of subjects enrolled
    United Kingdom: 6
    Worldwide total number of subjects
    87
    EEA total number of subjects
    7
    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)
    87
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This study was conducted at 26 centers in 8 countries between 09 July 2015 and 16 November 2016.

    Pre-assignment
    Screening details
    		 The study duration was approximately 18 weeks, consisting of a screening period including a 4-week single-blind placebo treatment for baseline assessments, a 12-week double-blind randomised treatment period, and a 2-week follow-up period. A total of 194 patients were enrolled in the study. A total of 87 patients were randomized.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PLACEBO 10MG BID + PLACEBO 45MG BID
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo for ticagrelor 45 mg + matching placebo for ticagrelor 10 mg, 1 tablet bd given orally.

    Arm title
    		 TICAGRELOR 10MG BID + PLACEBO 45MG BID
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ticagrelor
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ticagrelor 10 mg + matching placebo for ticagrelor 45 mg, 1 tablet bd given orally.

    Arm title
    		 TICAGRELOR 45MG BID + PLACEBO 10MG BID
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ticagrelor
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ticagrelor 45 mg + matching placebo for ticagrelor 10 mg, 1 tablet bd given orally.

    Number of subjects in period 1
    		PLACEBO 10MG BID + PLACEBO 45MG BID TICAGRELOR 10MG BID + PLACEBO 45MG BID TICAGRELOR 45MG BID + PLACEBO 10MG BID
    Started
    30
    27
    30
    Completed
    28
    24
    27
    Not completed
    2
    3
    3
         Consent withdrawn by subject
    2
    1
    2
         Did Not Fulfill Randomization Criteria
    -
    1
    -
         Dev. of Study-Spec. Withdrawal Criteria
    -
    -
    1
         Lost to follow-up
    -
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    PLACEBO 10MG BID + PLACEBO 45MG BID
    Reporting group description
    		 -

    Reporting group title
    TICAGRELOR 10MG BID + PLACEBO 45MG BID
    Reporting group description
    		 -

    Reporting group title
    TICAGRELOR 45MG BID + PLACEBO 10MG BID
    Reporting group description
    		 -

    Reporting group values
    		 PLACEBO 10MG BID + PLACEBO 45MG BID TICAGRELOR 10MG BID + PLACEBO 45MG BID TICAGRELOR 45MG BID + PLACEBO 10MG BID Total
    Number of subjects
    		 30 27 30 87
    Age categorical
    Units: Subjects
        Young adults (18-30 years)
    		 30 27 30 87
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 21.6 ( 3.42 ) 21.9 ( 2.72 ) 23.2 ( 3.69 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 16 15 16 47
        Male
    		 14 12 14 40
    Race, Customized
    Units: Subjects
        Black Or African American
    		 15 14 17 46
        Other
    		 0 1 0 1
        White
    		 15 12 13 40

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    PLACEBO 10MG BID + PLACEBO 45MG BID
    Reporting group description
    		 -

    Reporting group title
    TICAGRELOR 10MG BID + PLACEBO 45MG BID
    Reporting group description
    		 -

    Reporting group title
    TICAGRELOR 45MG BID + PLACEBO 10MG BID
    Reporting group description
    		 -

    Primary: Change in proportion of days with pain due to sickle cell disease as measured by an eDiary

    		 Close Top of page
    End point title
    		 Change in proportion of days with pain due to sickle cell disease as measured by an eDiary
    End point description
    To investigate the efficacy of 2 different doses of ticagrelor versus placebo in reducing the number of days with pain due to sickle cell disease.
    End point type
    Primary
    End point timeframe
    Baseline through Week 12
    End point values
    		 PLACEBO 10MG BID + PLACEBO 45MG BID TICAGRELOR 10MG BID + PLACEBO 45MG BID TICAGRELOR 45MG BID + PLACEBO 10MG BID
    Number of subjects analysed
    30
    27
    30
    Units: Proportion of days with pain
        least squares mean (confidence interval 90%)
    -0.1802 (-0.2673 to -0.0931)
    -0.1352 (-0.226 to -0.0444)
    -0.1001 (-0.1881 to -0.0121)
    Statistical analysis title
    		 Change in proportion of days with pain
    Comparison groups
    PLACEBO 10MG BID + PLACEBO 45MG BID v TICAGRELOR 10MG BID + PLACEBO 45MG BID
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.045
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.061
         upper limit
    		 0.151
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.06367
    Statistical analysis title
    		 Change in proportion of days with pain
    Comparison groups
    PLACEBO 10MG BID + PLACEBO 45MG BID v TICAGRELOR 45MG BID + PLACEBO 10MG BID
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.0801
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.023
         upper limit
    		 0.1832
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.06192

    Secondary: Average of the daily worst pain values reported via eDiary

    		 Close Top of page
    End point title
    		 Average of the daily worst pain values reported via eDiary
    End point description
    To determine the efficacy of 2 different doses of ticagrelor versus placebo in reducing the intensity of pain due to sickle cell disease.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 12
    End point values
    		 PLACEBO 10MG BID + PLACEBO 45MG BID TICAGRELOR 10MG BID + PLACEBO 45MG BID TICAGRELOR 45MG BID + PLACEBO 10MG BID
    Number of subjects analysed
    30
    27
    30
    Units: Average daily worst pain rating
        arithmetic mean (standard deviation)
    1.02 ( 1.106 )
    1.15 ( 1.547 )
    1.74 ( 2.277 )
    No statistical analyses for this end point

    Secondary: Change in proportion of days with analgesic use measured by an eDiary

    		 Close Top of page
    End point title
    		 Change in proportion of days with analgesic use measured by an eDiary
    End point description
    To assess the efficacy of 2 different doses of ticagrelor versus placebo in reducing the use of analgesics by patients with sickle cell disease.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 12
    End point values
    		 PLACEBO 10MG BID + PLACEBO 45MG BID TICAGRELOR 10MG BID + PLACEBO 45MG BID TICAGRELOR 45MG BID + PLACEBO 10MG BID
    Number of subjects analysed
    30
    27
    30
    Units: Proportion of days with analgesic use
        least squares mean (confidence interval 90%)
    -0.1991 (-0.2753 to -0.123)
    -0.0799 (-0.159 to -0.0008)
    -0.1016 (-0.1782 to -0.025)
    Statistical analysis title
    		 Change in proportion of days of analgesic use
    Comparison groups
    PLACEBO 10MG BID + PLACEBO 45MG BID v TICAGRELOR 10MG BID + PLACEBO 45MG BID
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.1192
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.035
         upper limit
    		 0.2035
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.05059
    Statistical analysis title
    		 Change in proportion of days of analgesic use
    Comparison groups
    PLACEBO 10MG BID + PLACEBO 45MG BID v TICAGRELOR 45MG BID + PLACEBO 10MG BID
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.0975
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.0155
         upper limit
    		 0.1795
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.04923

    Other pre-specified: Number of major bleeding or clinically relevant non-major bleeding events

    		 Close Top of page
    End point title
    		 Number of major bleeding or clinically relevant non-major bleeding events
    End point description
    To assess safety and tolerability of 2 different doses of ticagrelor versus placebo in patients with SCD
    End point type
    Other pre-specified
    End point timeframe
    Baseline through Week 12
    End point values
    		 PLACEBO 10MG BID + PLACEBO 45MG BID TICAGRELOR 10MG BID + PLACEBO 45MG BID TICAGRELOR 45MG BID + PLACEBO 10MG BID
    Number of subjects analysed
    30
    26
    30
    Units: Number of patients
        Total number of bleeding events
    2
    2
    2
        Patients with any bleeding events
    2
    2
    2
        Pts w/ any bleeding event requiring intervention
    2
    1
    2
        Maximum severity of bleeding event: Minor
    0
    1
    0
        Max sever. of bleed event: Clin-relevant nonmajor
    2
    1
    2
        Maximum severity of bleeding event: Major
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Includes AEs with an onset date on or after the first dose of study medication during the treatment period and through the date of the last dose of study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    PLACEBO 10MG BID + PLACEBO 45MG BID
    Reporting group description
    		 -

    Reporting group title
    TICAGRELOR 10MG BID + PLACEBO 45MG BID
    Reporting group description
    		 -

    Reporting group title
    TICAGRELOR 45MG BID + PLACEBO 10MG BID
    Reporting group description
    		 -

    Serious adverse events
    		 PLACEBO 10MG BID + PLACEBO 45MG BID TICAGRELOR 10MG BID + PLACEBO 45MG BID TICAGRELOR 45MG BID + PLACEBO 10MG BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 30 (20.00%)
    6 / 26 (23.08%)
    5 / 30 (16.67%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Face injury
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 26 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Vascular occlusion
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 26 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 26 (3.85%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Reticulocytopenia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 26 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sickle cell anaemia with crisis
         subjects affected / exposed
    3 / 30 (10.00%)
    5 / 26 (19.23%)
    3 / 30 (10.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Local swelling
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 26 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic ischaemia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 26 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute chest syndrome
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 26 (3.85%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 26 (3.85%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 26 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 26 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 26 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 26 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 26 (3.85%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PLACEBO 10MG BID + PLACEBO 45MG BID TICAGRELOR 10MG BID + PLACEBO 45MG BID TICAGRELOR 45MG BID + PLACEBO 10MG BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 30 (53.33%)
    15 / 26 (57.69%)
    20 / 30 (66.67%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 30 (26.67%)
    11 / 26 (42.31%)
    8 / 30 (26.67%)
         occurrences all number
    23
    25
    28
    Blood and lymphatic system disorders
    Sickle cell anaemia with crisis
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 26 (3.85%)
    2 / 30 (6.67%)
         occurrences all number
    3
    1
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 26 (3.85%)
    2 / 30 (6.67%)
         occurrences all number
    2
    1
    2
    Non-cardiac chest pain
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 26 (11.54%)
    4 / 30 (13.33%)
         occurrences all number
    4
    10
    10
    Pain
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 26 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    1
    0
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 30 (10.00%)
    5 / 26 (19.23%)
    3 / 30 (10.00%)
         occurrences all number
    4
    11
    3
    Nausea
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 26 (3.85%)
    3 / 30 (10.00%)
         occurrences all number
    1
    1
    3
    Toothache
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 26 (7.69%)
    0 / 30 (0.00%)
         occurrences all number
    1
    2
    0
    Vomiting
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 26 (7.69%)
    2 / 30 (6.67%)
         occurrences all number
    1
    3
    2
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 26 (3.85%)
    2 / 30 (6.67%)
         occurrences all number
    0
    1
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 26 (7.69%)
    0 / 30 (0.00%)
         occurrences all number
    0
    2
    0
    Epistaxis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 26 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    1
    0
    2
    Oropharyngeal pain
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 26 (7.69%)
    1 / 30 (3.33%)
         occurrences all number
    3
    3
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 30 (20.00%)
    6 / 26 (23.08%)
    9 / 30 (30.00%)
         occurrences all number
    23
    21
    47
    Back pain
         subjects affected / exposed
    7 / 30 (23.33%)
    4 / 26 (15.38%)
    4 / 30 (13.33%)
         occurrences all number
    20
    10
    12
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 26 (3.85%)
    2 / 30 (6.67%)
         occurrences all number
    0
    1
    7
    Musculoskeletal pain
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 26 (11.54%)
    3 / 30 (10.00%)
         occurrences all number
    2
    5
    9
    Pain in extremity
         subjects affected / exposed
    5 / 30 (16.67%)
    4 / 26 (15.38%)
    9 / 30 (30.00%)
         occurrences all number
    11
    12
    22
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 26 (7.69%)
    4 / 30 (13.33%)
         occurrences all number
    4
    2
    4
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 30 (13.33%)
    1 / 26 (3.85%)
    1 / 30 (3.33%)
         occurrences all number
    5
    1
    1
    Urinary tract infection
         subjects affected / exposed
    4 / 30 (13.33%)
    2 / 26 (7.69%)
    2 / 30 (6.67%)
         occurrences all number
    5
    2
    2

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Aug 2015
    Inclusion criterion of negative pregnancy test was moved from enrolment to at randomisation (Visit 2). Exclusion criteria related to liver function tests, known active or chronic infection, haemoglobin, and platelets moved from enrolment to randomisation (Visit 2). Exclusion criterion related to urine drug screen was removed.

    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
    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-Thu Apr 25 03:09:49 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA