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    Summary
    EudraCT Number:2010-022383-12
    Sponsor's Protocol Code Number:CCX114157
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-12-02
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNorway - NOMA
    A.2EudraCT number2010-022383-12
    A.3Full title of the trial
    A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease
    A.4.1Sponsor's protocol code numberCCX114157
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Research & Development Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGSK1605786A
    D.3.2Product code GSK1605786A
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGSK1605786A
    D.3.9.3Other descriptive nameN-{4-Chloro-2-[(1-oxido-4-pyridinyl)carbonyl]phenyl}-4-(1,1-dimethylethyl)benzenesulfonamidesodium
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects with Crohn's Disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the efficacy of GSK1605786A compared with placebo in maintaining
    clinical remission in subjects with Crohn’s disease over 52 weeks.
    E.2.2Secondary objectives of the trial
    • To evaluate the safety of GSK1605786A compared with placebo in subjects with
    Crohn’s disease.
    • To investigate the effect of GSK1605786A compared with placebo on health-related
    quality of life in subjects with Crohn’s disease.
    • To investigate the effect of GSK1605786A compared with placebo on healthcare
    related resource utilisation in subjects with Crohn’s disease.
    • To investigate the effect of GSK1605786A compared with placebo on work
    productivity in subjects with active Crohn’s disease.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects achieving clinical response (CDAI decrease ≥ 100points) and/or remission
    (CDAI <150) upon completion of treatment in Study CCX114151 or another GSK
    sponsored induction study
    2. Written informed consent prior to any CCX114157 specific study procedures
    3. Females of child-bearing potential must be sexually inactive or commit to use of
    consistent and correct use of contraceptive methods with a failure rate of < 1%, for
    the duration of this 52 week study as defined by the following:
    Abstinence
    Sexual inactivity by abstinence must be consistent with the preferred and usual
    lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
    Contraceptive Methods with a Failure Rate of < 1%
    • Oral contraceptive, either combined or progestogen alone
    • Injectable progestogen
    • Implants of levonorgestrel
    • Estrogenic vaginal ring
    • Percutaneous contraceptive patches
    • Intrauterine device (IUD) or intrauterine system (IUS) that meets the <1%
    failure rate as stated in the product label
    • Male partner sterilisation (vasectomy with documentation of azoospermia)
    prior to the female subject's entry into the study, and this male is the sole
    partner for that subject. For this definition, “documented” refers to the
    outcome of the investigator's/designee’s medical examination of the subject
    or review of the subject's medical history for study eligibility, as obtained via
    a verbal interview with the subject or from the subject’s medical records.
    • Double barrier method: condom and occlusive cap (diaphragm or
    cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository)
    These allowed methods of contraception are only effective when used consistently,
    correctly and in accordance with the product label. The investigator is responsible for
    ensuring subjects understand how to properly use these methods of contraception.
    Female subjects should not be enrolled if they are pregnant or lactating or if they plan to become pregnant during the time of study participation. For women of childbearing potential, a urine pregnancy test will be performed on the morning of the randomisation visit and at repeated intervals throughout the study.
    4. Any medications being currently received for Crohn’s disease must remain stable
    throughout the study period with the exception of tapering of corticosteroids
    5. Subjects on corticosteroids at entry must be willing to undergo corticosteroid dose
    tapering
    Note: Country-specific requirement for French subjects: In France, a subject will be
    eligible for inclusion in this study only if either affiliated to or a beneficiary of a social
    security category.
    E.4Principal exclusion criteria
    1. If female, is pregnant, has a positive pregnancy test or is breast-feeding
    2. Subjects with known or suspected coeliac disease or a positive screening test (antitissue
    transglutaminase antibodies) should have been excluded from enrolment into
    the induction studies. Subjects in whom a diagnosis of coeliac disease is
    subsequently suspected should have this excluded with testing for anti- tissue
    transglutaminase antibodies prior to enrolment into the maintenance study.
    3. Known or suspected small bowel stricture
    4. Enterocutaneous , abdominal or pelvic fistulae likely to require surgery during the
    study period
    5. Current sepsis or infections requiring intravenous antibiotic therapy >2 weeks
    6. Evidence of hepatic dysfunction, viral hepatitis, or liver function abnormalities:
    Exhibits serum ALT (SGPT) and/or AST (SGOT) values ≥2 times the upper limit of
    normal, or has a total bilirubin value ≥1.5 times the upper limit of normal: has
    alkaline phosphatase ≥ 1.5 times the upper limit of normal; has current or chronic
    history of liver disease including non-alcoholic steatohepatitis (NASH) or known
    hepatic or biliary abnormalities with the exception of Gilbert’s syndrome or
    asymptomatic gallstones.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy endpoints:

    Proportion of subjects in clinical remission (CDAI score <150 points) at both Weeks 28 and 52 of the 52-week treatment period
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA54
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Subject Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 750
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The investigator is responsible for maintaining the post study care of a patient’s medical condition. Subjects, on completion of the study after 52 weeks, may be eligible for an open-label study with GSK1605786A (study CCX114644). Subjects who do not enter study CCX114644 will not receive further treatment provided by GSK but will return for a Follow-up visit at Week 56. Subsequent treatment for Crohn’s disease will be at the discretion of the investigator.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-12-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-09-04
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