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   43851   clinical trials with a EudraCT protocol, of which   7283   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 II Open-label Rollover Study for Subjects that have Participated in a Linsitinib Trial

    Summary
    EudraCT number
    		 2013-004076-34
    Trial protocol
    		 CZ   PL   GB  
    Global end of trial date
    21 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Dec 2017
    First version publication date
    27 Dec 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    7487-CL-0209
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02057380
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Astellas Pharma Global Development (APGD) US
    Sponsor organisation address
    1 Astellas Way, Northbrook, United States, 60062
    Public contact
    Clinical Trial Disclosure, Astellas Pharma Global Development (APGD) US, astellas.resultsdisclosure@astellas.com
    Scientific contact
    Clinical Trial Disclosure, Astellas Pharma Global Development (APGD) US, astellas.resultsdisclosure@astellas.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
    21 Dec 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to provide access to continued treatment for participants who took part in other linsitinib Astellas sponsored trials and for whom the investigator feels the participants may benefit from continued treatment.
    Protection of trial subjects
    This clinical study was written, conducted and reported in accordance with the protocol, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, and applicable local regulations, including the European Directive 2001/20/EC, on the protection of human rights, and with the ethical principles that have their origin in the Declaration of Helsinki. Astellas ensures that the use and disclosure of protected health information (PHI) obtained during a research study complies with the federal, national and/or regional legislation related to the privacy and protection of personal information.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Apr 2014
    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 States: 5
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Brazil: 1
    Country: Number of subjects enrolled
    Czech Republic: 1
    Country: Number of subjects enrolled
    Poland: 2
    Country: Number of subjects enrolled
    Singapore: 1
    Country: Number of subjects enrolled
    Thailand: 1
    Worldwide total number of subjects
    13
    EEA total number of subjects
    5
    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)
    6
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This was a phase 2, open-label, rollover study for adult participants with advanced solid tumors who previously participated in the completed linsitinib studies conducted across 42 centers.

    Pre-assignment
    Screening details
    		 Participants continued with the regimen and study drug dose they received during the previous linsitinib study, including linsitinib alone or in combination with other approved cancer treatments such as erlotinib or paclitaxel, or erlotinib alone. During the study, one participant was incorrectly identified as coming from Arm C instead of Arm B.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A: Linsitinib 150 mg BID
    Arm description
    		 Participants received 150 mg of linsitinib orally twice a day (BID).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Linsitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received linsitinib orally twice a day with food and up to 200 ml of water at approximately the same time each day. Two doses of linsitinib were received 12 hours apart.

    Arm title
    		 Arm C: Erlotinib 150 mg QD
    Arm description
    		 Participants received 150 mg of erlotinib orally once a day (QD).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Erlotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received erlotinib orally at least one hour before or two hours after food with up to 200 ml of water.

    Arm title
    		 Arm D: Linsitinib 150 mg BID + Paclitaxel
    Arm description
    		 Participants received 150 mg of linsitinib orally twice a day (BID) with weekly paclitaxel as an IV infusion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received paclitaxel as an IV infusion according to institution practice and product package insert.

    Investigational medicinal product name
    Linsitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received linsitinib orally twice a day with food and up to 200 ml of water at approximately the same time each day. Two doses of linsitinib were received 12 hours apart.

    Arm title
    		 Arm H: Linsitinib 150 mg BID
    Arm description
    		 Participants received 150 mg of linsitinib orally twice a day (BID) for 28 days each cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Linsitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received linsitinib orally twice a day with food and up to 200 ml of water at approximately the same time each day. Two doses of linsitinib were received 12 hours apart.

    Number of subjects in period 1
    		Arm A: Linsitinib 150 mg BID Arm C: Erlotinib 150 mg QD Arm D: Linsitinib 150 mg BID + Paclitaxel Arm H: Linsitinib 150 mg BID
    Started
    2
    8
    2
    1
    Completed
    0
    4
    2
    0
    Not completed
    2
    4
    0
    1
         Treatment Discontinued due to Disease Progression
    2
    4
    -
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 Overall Study

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 13 13
    Age categorical
    Units: Subjects
        47-78 years
    		 13 13
    Gender categorical
    Units:
        Male
    		 2 2
        Female
    		 11 11
    Ethnicity and Race
    Units: Subjects
        White
    		 7 7
        Hispanic or Latino
    		 1 1
        Asian
    		 2 2
        Race Not Collected
    		 3 3

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Arm A: Linsitinib 150 mg BID
    Reporting group description
    		 Participants received 150 mg of linsitinib orally twice a day (BID).

    Reporting group title
    Arm C: Erlotinib 150 mg QD
    Reporting group description
    		 Participants received 150 mg of erlotinib orally once a day (QD).

    Reporting group title
    Arm D: Linsitinib 150 mg BID + Paclitaxel
    Reporting group description
    		 Participants received 150 mg of linsitinib orally twice a day (BID) with weekly paclitaxel as an IV infusion.

    Reporting group title
    Arm H: Linsitinib 150 mg BID
    Reporting group description
    		 Participants received 150 mg of linsitinib orally twice a day (BID) for 28 days each cycle.

    Primary: Number of Participants with Adverse Events

    		 Close Top of page
    End point title
    		 Number of Participants with Adverse Events [1]
    End point description
    Safety was assessed by evaluation of treatment-emergent adverse events (TEAEs), clinical laboratory variables, vital signs, physical examination and the 12 lead electrocardiogram (ECG). A TEAE was defined as an adverse event (AE) with an onset date on or after the administration of study drug or any ongoing AE that worsened in severity up to 30 days after administration of the last dose of study drug. One participant was incorrectly identified in the listings as coming from Arm C instead of Arm B based on interactive response technology (IRT) data used to assign treatment arms. Treatment in Arm B consisted of 150 mg linsitinib twice a day plus 150 mg of erlotinib once a day. Analysis population was safety analysis set (SAF) and it consisted of all participants who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    From first dose of study drug until 30 days after last dose; maximum duration of treatment was 925 days
    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: Statistical analysis was not completed for this endpoint.
    End point values
    		 Arm A: Linsitinib 150 mg BID Arm C: Erlotinib 150 mg QD Arm D: Linsitinib 150 mg BID + Paclitaxel Arm H: Linsitinib 150 mg BID
    Number of subjects analysed
    2
    8
    2
    1
    Units: Participants
        Any AE
    2
    8
    2
    1
        Any TEAE
    2
    6
    1
    1
        Deaths
    0
    0
    0
    0
        Serious TEAEs
    1
    3
    1
    1
        TEAEs Leading to Discontinuation
    0
    0
    1
    0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug until 30 days after last dose; maximum duration of treatment was 925 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Arm A: Linsitinib 150 mg BID
    Reporting group description
    		 Participants received 150 mg of linsitinib orally twice a day (BID).

    Reporting group title
    Arm C: Erlotinib 150 mg QD
    Reporting group description
    		 Participants received 150 mg of erlotinib orally once a day (QD).

    Reporting group title
    Arm D: Linsitinib 150 mg BID + Paclitaxel
    Reporting group description
    		 Participants received 150 mg of linsitinib orally twice a day (BID) with weekly paclitaxel as an IV infusion.

    Reporting group title
    Arm H: Linsitinib 150 mg BID
    Reporting group description
    		 Participants received 150 mg of linsitinib orally twice a day (BID) for 28 days each cycle.

    Serious adverse events
    		 Arm A: Linsitinib 150 mg BID Arm C: Erlotinib 150 mg QD Arm D: Linsitinib 150 mg BID + Paclitaxel Arm H: Linsitinib 150 mg BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 2 (50.00%)
    3 / 8 (37.50%)
    1 / 2 (50.00%)
    1 / 1 (100.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (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
    Gastrointestinal disorders
    Ileus
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (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
    Vomiting
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (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
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (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
    Viral infection
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (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: 5%
    Non-serious adverse events
    		 Arm A: Linsitinib 150 mg BID Arm C: Erlotinib 150 mg QD Arm D: Linsitinib 150 mg BID + Paclitaxel Arm H: Linsitinib 150 mg BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 2 (100.00%)
    6 / 8 (75.00%)
    1 / 2 (50.00%)
    1 / 1 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 2 (0.00%)
    2 / 8 (25.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Throat irritation
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Wheezing
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Investigations
    Intraocular pressure increased
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Red blood cells urine positive
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vitamin D decreased
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    White blood cells urine positive
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Wrist fracture
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    0
    0
    1
    Aphasia
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dizziness
         subjects affected / exposed
    0 / 2 (0.00%)
    2 / 8 (25.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Headache
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear and labyrinth disorders
    Deafness transitory
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ear pain
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Duodenogastric reflux
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastritis
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hiatus hernia
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Loose tooth
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dermatitis allergic
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Drug eruption
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    4
    0
    0
    Dry skin
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Haemorrhage subcutaneous
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nail ridging
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal and urinary disorders
    Bilirubinuria
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Haematuria
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Proteinuria
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Muscle spasms
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    0
    0
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nail infection
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Paronychia
         subjects affected / exposed
    0 / 2 (0.00%)
    2 / 8 (25.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Food intolerance
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vitamin D deficiency
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jul 2015
    There was 1 substantial amendment to the protocol that expanded eligibility criteria, lengthened the planned study period and the duration of participants treatment and clarified local requirements for adverse events (AEs).

    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-Sat Apr 20 04:08:32 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA