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   43865   clinical trials with a EudraCT protocol, of which   7286   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 Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multi-Dose, Cross-Over, Efficacy and Safety Study of IPI-145 in Mild Asthmatic Subjects Undergoing Allergen Challenge

    Summary
    EudraCT number
    		 2012-001729-28
    Trial protocol
    		 GB   DE  
    Global end of trial date
    30 Jul 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    25 Nov 2023
    First version publication date
    16 Aug 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Results contact info has changed.
    Summary report(s)
    		 IPI-145-03_Clinical_Study_Report_Synopsis_FINAL_150720

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IPI-145-03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Secura Bio, Inc.
    Sponsor organisation address
    1995 Village Center Circle, Suite 128, Las Vegas, NV, United States, 89134
    Public contact
    Beth Gregory, PharmD, MBA, Secura Bio, Inc., 1 702-254-0011, bgregory@securabio.com
    Scientific contact
    Beth Gregory, PharmD, MBA, Secura Bio, Inc., 1 702-254-0011, bgregory@securabio.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
    24 Sep 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Examine the effects of multi-dose regimens of different dose strengths of IPI-145 on lung function in asthmatic subjects following allergen challenge
    Protection of trial subjects
    The Sponsor conducted internal safety reviews after Cohorts 1 and 2 and after the first 5 subjects were enrolled in Cohort 3 (prior to completing enrollment in this cohort). Teleconferences occurred between the Sponsor and Principal Investigators and their staff to discuss study conduct progress and any safety matters. The final study protocol and its amendments, including the final version of the informed consent form (ICF), was approved or given a favorable opinion in writing by an Independent Ethics Committee (IEC) at each clinical trial site. The Principal Investigator had to submit written approval to Infinity before he or she could enroll any subject into the study. The Principal Investigator was responsible for informing the IEC of any amendment to the protocol. In addition, the IEC approved all advertising used to recruit subjects for the study. Progress reports and notifications of serious adverse events (SAEs) were provided to the IEC according to regulations and guidelines. The study was conducted in accordance with the principles of the Declaration of Helsinki in place at the time of study conduct. The study was conducted in compliance with the International Conference on Harmonisation (ICH) E6 Guideline for Good Clinical Practice (GCP) (Committee for Proprietary Medicinal Products [CPMP] guideline CPMP/ICH/135/95), and compliant with the European Union Clinical Trial Directive (EU CTD): Directive 2001/20/EC, and all applicable local regulatory requirements. Written informed consent was obtained from all subjects prior to any study screening procedures and subsequent enrollment into the study. The information recorded for all consented subjects, regardless of their suitability for the study, was retained and archived.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Jul 2012
    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
    United Kingdom: 24
    Country: Number of subjects enrolled
    Germany: 26
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    50
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 50
    Number of subjects completed
    		 49

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Subject discontinuted prior to first treatment: 1
    Period 1
    Period 1 title
    Treatment period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IPI-145+Placebo (Cohort 1)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    IPI-145
    Investigational medicinal product code
    PR1
    Other name
    Duvelisib
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg Q12h

    Arm title
    		 IPI-145+Placebo (Cohort 2)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    IPI-145
    Investigational medicinal product code
    PR2
    Other name
    Duvelisib
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg Q12h

    Arm title
    		 IPI-145+Placebo (Cohort 3)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    IPI-145
    Investigational medicinal product code
    PR3
    Other name
    Duvelisib
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    25 mg Q12h

    Number of subjects in period 1 [1]
    		IPI-145+Placebo (Cohort 1) IPI-145+Placebo (Cohort 2) IPI-145+Placebo (Cohort 3)
    Started
    13
    18
    18
    Completed
    11
    18
    18
    Not completed
    2
    0
    0
         Physician decision
    1
    -
    -
         Adverse event, non-fatal
    1
    -
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline characteristics reported only for participants that received study treatment.
    Period 2
    Period 2 title
    Treatment period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IPI-145+Placebo (Cohort 1)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    IPI-145
    Investigational medicinal product code
    PR1
    Other name
    Duvelisib
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg Q12h

    Arm title
    		 IPI-145+Placebo (Cohort 2)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    IPI-145
    Investigational medicinal product code
    PR2
    Other name
    Duvelisib
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg Q12h

    Arm title
    		 IPI-145+Placebo (Cohort 3)
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    IPI-145
    Investigational medicinal product code
    PR3
    Other name
    Duvelisib
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    25 mg Q12h

    Number of subjects in period 2
    		IPI-145+Placebo (Cohort 1) IPI-145+Placebo (Cohort 2) IPI-145+Placebo (Cohort 3)
    Started
    11
    18
    18
    Completed
    11
    18
    18

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Treatment period 1
    Reporting group description
    		 -

    Reporting group values
    		 Treatment period 1 Total
    Number of subjects
    		 49 49
    Age categorical
    Units: Subjects
        18-29 years
    		 19 19
        30-39 years
    		 12 12
        40-49 years
    		 13 13
        50-60 years
    		 5 5
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 35.8 (21 to 59) -
    Gender categorical
    Units: Subjects
        Female
    		 15 15
        Male
    		 34 34
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects who received at least one dose of study drug (IPI-145 or matching placebo)

    Subject analysis set title
    IPI-145 cohort 1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All Cohort 1 subjects in the full analysis set who completed allergen challenge in Treatment Period 1 and Treatment Period 2

    Subject analysis set title
    Placebo cohort 1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All Cohort 1 subjects in the full analysis set who completed allergen challenge in Treatment Period 1 and Treatment Period 2

    Subject analysis set title
    IPI-145 cohort 2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All Cohort 2 subjects in the full analysis set who completed allergen challenge in Treatment Period 1 and Treatment Period 2

    Subject analysis set title
    Placebo cohort 2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All Cohort 2 subjects in the full analysis set who completed allergen challenge in Treatment Period 1 and Treatment Period 2

    Subject analysis set title
    IPI-145 cohort 3
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All Cohort 3 subjects in the full analysis set who completed allergen challenge in Treatment Period 1 and Treatment Period 2

    Subject analysis set title
    Placebo cohort 3
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All Cohort 3 subjects in the full analysis set who completed allergen challenge in Treatment Period 1 and Treatment Period 2

    Subject analysis set title
    Cohort 1 PK analysis
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with sufficient IPI-145 plasma concentrations

    Subject analysis set title
    Cohort 2 PK analysis
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with sufficient IPI-145 plasma concentrations

    Subject analysis set title
    Cohort 3 PK analysis
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with sufficient IPI-145 plasma concentrations

    Subject analysis sets values
    		 Full analysis set IPI-145 cohort 1 Placebo cohort 1 IPI-145 cohort 2 Placebo cohort 2 IPI-145 cohort 3 Placebo cohort 3 Cohort 1 PK analysis Cohort 2 PK analysis Cohort 3 PK analysis
    Number of subjects
    49
    10
    10
    17
    17
    16
    16
    12
    18
    18
    Age categorical
    Units: Subjects
        18-29 years
    19
        30-39 years
    12
        40-49 years
    13
        50-60 years
    5
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    35.8 (21 to 59)
    Gender categorical
    Units: Subjects
        Female
    15
        Male
    34

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    IPI-145+Placebo (Cohort 1)
    Reporting group description
    		 -

    Reporting group title
    IPI-145+Placebo (Cohort 2)
    Reporting group description
    		 -

    Reporting group title
    IPI-145+Placebo (Cohort 3)
    Reporting group description
    		 -
    Reporting group title
    IPI-145+Placebo (Cohort 1)
    Reporting group description
    		 -

    Reporting group title
    IPI-145+Placebo (Cohort 2)
    Reporting group description
    		 -

    Reporting group title
    IPI-145+Placebo (Cohort 3)
    Reporting group description
    		 -

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects who received at least one dose of study drug (IPI-145 or matching placebo)

    Subject analysis set title
    IPI-145 cohort 1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All Cohort 1 subjects in the full analysis set who completed allergen challenge in Treatment Period 1 and Treatment Period 2

    Subject analysis set title
    Placebo cohort 1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All Cohort 1 subjects in the full analysis set who completed allergen challenge in Treatment Period 1 and Treatment Period 2

    Subject analysis set title
    IPI-145 cohort 2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All Cohort 2 subjects in the full analysis set who completed allergen challenge in Treatment Period 1 and Treatment Period 2

    Subject analysis set title
    Placebo cohort 2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All Cohort 2 subjects in the full analysis set who completed allergen challenge in Treatment Period 1 and Treatment Period 2

    Subject analysis set title
    IPI-145 cohort 3
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All Cohort 3 subjects in the full analysis set who completed allergen challenge in Treatment Period 1 and Treatment Period 2

    Subject analysis set title
    Placebo cohort 3
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All Cohort 3 subjects in the full analysis set who completed allergen challenge in Treatment Period 1 and Treatment Period 2

    Subject analysis set title
    Cohort 1 PK analysis
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with sufficient IPI-145 plasma concentrations

    Subject analysis set title
    Cohort 2 PK analysis
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with sufficient IPI-145 plasma concentrations

    Subject analysis set title
    Cohort 3 PK analysis
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with sufficient IPI-145 plasma concentrations

    Primary: Maximal decrease from pre-allergen challenge in FEV1 following allergen challenge in the early asthmatic response [EAR]

    		 Close Top of page
    End point title
    		 Maximal decrease from pre-allergen challenge in FEV1 following allergen challenge in the early asthmatic response [EAR]
    End point description
    End point type
    Primary
    End point timeframe
    Before and after each allergen challenge of each treatment period
    End point values
    		 IPI-145 cohort 1 Placebo cohort 1 IPI-145 cohort 2 Placebo cohort 2 IPI-145 cohort 3 Placebo cohort 3
    Number of subjects analysed
    10
    10
    17
    17
    16
    16
    Units: Liters
        least squares mean (standard error)
    -0.885 ± 0.154
    -0.958 ± 0.154
    -0.938 ± 0.141
    -0.945 ± 0.141
    -0.993 ± 0.093
    -0.97 ± 0.093
    Statistical analysis title
    		 Mixed-effects model for a crossover design
    Statistical analysis description
    The number of subjects included in this analysis are exactly half of the number of subjects reported below, because this is a cross-over design in which each subject receives both treatments (IPI-145 and placebo).
    Comparison groups
    IPI-145 cohort 1 v Placebo cohort 1
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4571
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Mixed-effects model for a crossover design
    Statistical analysis description
    The number of subjects included in this analysis are exactly half of the number of subjects reported below, because this is a cross-over design in which each subject receives both treatments (IPI-145 and placebo).
    Comparison groups
    IPI-145 cohort 2 v Placebo cohort 2
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.941
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Mixed-effects model for a crossover design
    Statistical analysis description
    The number of subjects included in this analysis are exactly half of the number of subjects reported below, because this is a cross-over design in which each subject receives both treatments (IPI-145 and placebo).
    Comparison groups
    IPI-145 cohort 3 v Placebo cohort 3
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8021
    Method
    		 Mixed models analysis
    Confidence interval

    Primary: Maximal decrease from pre-allergen challenge in FEV1 following allergen challenge in the late asthmatic response [LAR]

    		 Close Top of page
    End point title
    		 Maximal decrease from pre-allergen challenge in FEV1 following allergen challenge in the late asthmatic response [LAR]
    End point description
    End point type
    Primary
    End point timeframe
    Day 14: post-allergen challenge LAR
    End point values
    		 IPI-145 cohort 1 Placebo cohort 1 IPI-145 cohort 2 Placebo cohort 2 IPI-145 cohort 3 Placebo cohort 3
    Number of subjects analysed
    10
    10
    17
    17
    16
    16
    Units: Liters
        least squares mean (standard error)
    -1.054 ± 0.14
    -0.874 ± 0.14
    -1.094 ± 0.172
    -0.99 ± 0.172
    -0.597 ± 0.09
    -0.773 ± 0.09
    Statistical analysis title
    		 Mixed-effects model for a crossover design
    Statistical analysis description
    The number of subjects included in this analysis are exactly half of the number of subjects reported below, because this is a cross-over design in which each subject receives both treatments (IPI-145 and placebo).
    Comparison groups
    IPI-145 cohort 1 v Placebo cohort 1
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1599
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Mixed-effects model for a crossover design
    Statistical analysis description
    The number of subjects included in this analysis are exactly half of the number of subjects reported below, because this is a cross-over design in which each subject receives both treatments (IPI-145 and placebo).
    Comparison groups
    Placebo cohort 2 v IPI-145 cohort 2
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2497
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Mixed-effects model for a crossover design
    Statistical analysis description
    The number of subjects included in this analysis are exactly half of the number of subjects reported below, because this is a cross-over design in which each subject receives both treatments (IPI-145 and placebo).
    Comparison groups
    IPI-145 cohort 3 v Placebo cohort 3
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0517
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: AUC of FEV1 following allergen challenge

    		 Close Top of page
    End point title
    		 AUC of FEV1 following allergen challenge
    End point description
    End point type
    Secondary
    End point timeframe
    From pre-challenge to 10 hours post-challenge in each treatment period
    End point values
    		 IPI-145 cohort 1 Placebo cohort 1 IPI-145 cohort 2 Placebo cohort 2 IPI-145 cohort 3 Placebo cohort 3
    Number of subjects analysed
    10
    10
    17
    17
    16
    16
    Units: Liters
        least squares mean (standard error)
    -0.491 ± 0.083
    -0.361 ± 0.085
    -0.534 ± 0.054
    -0.524 ± 0.052
    -0.258 ± 0.05
    -0.456 ± 0.053
    No statistical analyses for this end point

    Secondary: Cmax

    		 Close Top of page
    End point title
    		 Cmax
    End point description
    End point type
    Secondary
    End point timeframe
    From 0 to 12 hours post-dose (IPI-145)
    End point values
    		 Cohort 1 PK analysis Cohort 2 PK analysis Cohort 3 PK analysis
    Number of subjects analysed
    12
    18
    18
    Units: ng/ml
        arithmetic mean (standard deviation)
    50.15 ± 15.978
    244.78 ± 90.169
    1347.33 ± 728.671
    No statistical analyses for this end point

    Secondary: AUC

    		 Close Top of page
    End point title
    		 AUC
    End point description
    End point type
    Secondary
    End point timeframe
    From 0 to 12 hours post-dose (IPI-145)
    End point values
    		 Cohort 1 PK analysis Cohort 2 PK analysis Cohort 3 PK analysis
    Number of subjects analysed
    12
    18
    18
    Units: ng x h/ml
        arithmetic mean (standard deviation)
    149.94 ± 41.396
    796.64 ± 253.6
    5663.91 ± 3262.805
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    All AEs will be recorded from the time of informed consent until 21 days after the last dose of study drug. Subjects will be instructed to report all AEs and will be asked a general health status question at each study visit.
    Adverse event reporting additional description
    AEs reported by at least 2 subjects while on any dose of IPI-145
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    IPI-145 (Cohort 1)
    Reporting group description
    		 -

    Reporting group title
    IPI-145 (Cohort 2)
    Reporting group description
    		 -

    Reporting group title
    IPI-145 (Cohort 3)
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 IPI-145 (Cohort 1) IPI-145 (Cohort 2) IPI-145 (Cohort 3) Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 48 (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: 4%
    Non-serious adverse events
    		 IPI-145 (Cohort 1) IPI-145 (Cohort 2) IPI-145 (Cohort 3) Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 12 (75.00%)
    12 / 18 (66.67%)
    7 / 18 (38.89%)
    29 / 48 (60.42%)
    General disorders and administration site conditions
    Headache
         subjects affected / exposed
    4 / 12 (33.33%)
    7 / 18 (38.89%)
    4 / 18 (22.22%)
    17 / 48 (35.42%)
         occurrences all number
    9
    12
    7
    29
    Nausea
         subjects affected / exposed
    1 / 12 (8.33%)
    3 / 18 (16.67%)
    1 / 18 (5.56%)
    3 / 48 (6.25%)
         occurrences all number
    9
    12
    7
    29
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    1 / 48 (2.08%)
         occurrences all number
    9
    12
    7
    29
    Dyspepsia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    0 / 48 (0.00%)
         occurrences all number
    9
    12
    7
    29
    Respiratory, thoracic and mediastinal disorders
    Nasopharyngitis
         subjects affected / exposed
    5 / 12 (41.67%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    8 / 48 (16.67%)
         occurrences all number
    9
    12
    7
    29
    Cough
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    9
    12
    7
    29

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Jun 2012
    Protocol Amendment 1 (UK only)
    01 Aug 2012
    Protocol Amendment 1 (Germany only)
    10 Oct 2012
    Protocol Amendment 2 (UK only)
    29 Jan 2013
    Protocol Amendment 3
    22 Jan 2014
    Protocol Amendment 4

    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-Mon Apr 29 17:20:58 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA