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    Summary
    EudraCT Number:2004-000611-25
    Sponsor's Protocol Code Number:197-02-220
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2004-08-16
    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 ConcernedIreland - HPRA
    A.2EudraCT number2004-000611-25
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis.
    A.3.2Name or abbreviated title of the trial where available
    CORE
    A.4.1Sponsor's protocol code number197-02-220
    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 SponsorOtsuka Maryland Research Institute, Inc.
    B.1.3.4CountryUnited States
    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 Information not present in EudraCT
    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 nameOPC-6535
    D.3.2Product code OPC-6535
    D.3.4Pharmaceutical form Tablet
    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.3.9.2Current sponsor codeOPC-6535
    D.3.9.3Other descriptive name6-[2-(3,4-diethoxyphenyl)thiazol-4-yl] pyridine-2-carboxylic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Asacol (mesalamine) Delayed-release Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderProcter & Gamble Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameAsacol
    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 INNMesalamine
    D.3.9.3Other descriptive name5-amino-2-hydroxybenzoic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    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
    Maintenance of remission of ulcerative colitis
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The study will compare the safety and efficacy of 25 mg QD and 50 mg QD of OPC-6535 to 800 mg BID of Asacol® in the maintenance of remission in subjects with ulcerative colitis.

    The primary efficacy measure is time to treatment failure, defined as (1) relapse of ulcerative colitis or (2) discontinuation from the study for any other reason. Relapse is defined as either (RB ≥ 1 and FS ≥1) or the need for other medication for treatment of an acute flare, as judged by the principal investigator. OPC-6535 25 mg QD and OPC-6535 50 mg QD will be compared to Asacol®. 800 mg BID for noninferiority and then for superiority—for a treatment duration of 26 weeks.
    E.2.2Secondary objectives of the trial
    Efficacy:
    1.Time to relapse for a treatment duration of 26 weeks.
    2.Proportion of randomized subjects at Week 26&52 who are not treatment failures
    3.Time to treatment failure for a treatment duration of 26&52 weeks.
    4.Proportion of randomized subjects at Week 52 with endoscopic relapse
    5.Change from baseline in health related quality of life at Weeks 26 and 52, based on the Inflammatory Bowel Disease Questionnaire.
    6.At Weeks 26&52, the proportion of randomized subjects who are not treatment failures and the times to treatment failure in 3 treatment groups.
    7.Changes from baseline in the stool frequency, bleeding, bowel urgency, abdominal pain and general well being scores.
    Safety: Vital signs, ECGs, laboratory studies (including hematology, clinical chemistry, and urinalysis), and adverse events.
    Pharmacokinetics: OPC-6535 plasma concentrations.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Male or female subjects, 18 to 80 years of age, inclusive, who provide written, informed consent prior to any study-related procedures and who are, in the opinion of the Investigator, likely to comply with all the requirements of the study.
    2. Subjects with a prior diagnosis of ulcerative colitis, established by colonoscopy.
    3. Subjects currently in remission, defined as rectal bleeding (RB) score of 0 and flexible sigmoidoscopy (FS) score of 0 (screening flexible sigmoidoscopy or colonoscopy).
    4. Subjects who have undergone treatment for a flare of ulcerative colitis, with symptomatic onset of remission occurring no more than 52 weeks from the Screening Period.
    5. If subjects are taking sulfasalazine or 5-ASA products prior to entry, the dose must be stable for at least 6 weeks prior to the Screening Period. NOTE: During the study, use of these drugs will be discontinued
    6. Subjects having undergone colonoscopy with pan-colonic surveillance biopsies negative for dysplasia within 1 year of the Screening Visit if at increased risk of colorectal cancer (≥ 8 year history of ulcerative colitis). [Colonoscopy with pan-colonic surveillance biopsies for dysplasia will be substituted for flexible sigmoidoscopy during Screening if this inclusion criterion is not met.]
    7. Female or male subjects who are surgically sterilized or who are prepared to and agree to practice a double-barrier form of birth control from the Screening Period through 30 days (females) and 90 days (males), respectively, from the last dose of study medication. Females who are more than 12 months post-menopausal are also eligible to participate in the study. [See Section 5.4 for a description of acceptable forms of birth control.]
    E.4Principal exclusion criteria
    1. Subjects who have active disease, defined as a RB ≥ 1 or FS ≥ 1 during the Screening Period.
    2. Subjects who have any other clinically significant disease(s) or condition/procedure(s) which, in the opinion of the Investigator, could compromise the subject’s involvement in the study and/or interfere with the absorption of the study drug or the overall interpretation of the data.
    3. Subjects who have had major gastrointestinal surgery including, but not limited to, a colostomy, an ileostomy or previous colonic surgery other than appendectomy.
    4. Subjects who have used oral or intravenous corticosteroids or intrarectal topical agents (corticosteroid or 5-ASA enemas, suppositories, foams) within 6 weeks of the Screening Period.
    5. Subjects who have used azathioprine, 6-mercaptopurine or methotrexate within 6 weeks of the screening period or other immunosuppressive agents including, but not limited to IL-10, IL-11, FK-506 [tacrolimus], mycophenalate, cyclosporin, anti-TNF-a or a monoclonal antibody within 8 weeks of the Screening Period.
    6. Subjects who have a history or evidence of an active malignancy within the previous 5 years (surgically-treated basal cell, squamous cell or in-situ cervical carcinomas permissible), an intra-abdominal abscess, a toxic megacolon, or a clinical instability resulting from any other cause.
    7. Subjects with a known or suspected history of sclerosing cholangitis.
    8. Subjects with partial bowel obstruction, as documented by proximal small bowel dilatation during the Screening Period.
    9. Female subjects who are pregnant or lactating.
    10. Female subjects who are likely to undergo an in vitro fertilization (IVF ) procedure from the Screening Period through 30 days after the last dose of study medication, OR male subjects likely to participate in an IVF procedure from the Screening Period through 90 days after the last dose of study medication.
    11. Subjects with compromised hepatic function, characterized by ALT and/or AST levels twice (2x) the upper normal limit and/or a serum bilirubin > 1.7 mg/dL (unless the subject has been diagnosed with Gilbert’s syndrome) based on clinical laboratory results.
    12. Subjects with compromised renal function, characterized by serum creatinine levels 1.5 times the upper normal limit
    13. Subjects with a platelet count <100,000 or >750,000/mm3 based on clinical laboratory results.
    14. Subjects with severe anemia, defined as hemoglobin of <8.0 g/dL based on clinical laboratory results.
    15. Subjects with a serum albumin <2.5 g/dL based on clinical laboratory results.
    16. Subjects with a prothrombin time INR > 1.2 based on clinical laboratory results.
    17. Subjects with a neutrophil count of <2000/mm3 based on clinical laboratory results.
    18. Subjects taking > 325 mg aspirin/day or chronic (> 7 consecutive days) NSAID or COX-2 inhibitor use within 7 days of the Screening Period.
    19. Subjects who have used antibiotics, other than topical antibiotics, within 14 days of the Screening Period. [NOTE: Oral antibiotic use will be permitted after randomization for up to 7 consecutive days for non-serious infections at the discretion of the investigator. See table 4.1-1]
    20. Subjects taking warfarin (phenprocoumon) within 7 days of the Screening Period, or who are likely to take warfarin (phenprocoumon).
    21. (Intentionally left blank)
    22. Subjects taking pharmaceutical nicotine within 14 days of the Screening Period, or who are likely to take pharmaceutical nicotine.
    23. Subjects with a history of known or suspected alcohol or drug abuse within 6 months of the Screening Period.
    24. Subjects who receive any experimental drug or procedure within 30 days of the Screening Period, or who are likely to receive an experimental drug or procedure during the study through the 14-day period after the final administration of study drug. [An experimental agent is defined as any compound assessed under an IND.]
    25. Subjects who have taken any experimental agents with documented or potential immunosuppressive effects within 90 days prior to Screening Period.
    26. Subjects taking sulfasalazine or 5-ASA containing products who have undergone a dose change within 6 weeks of the Screening Period. NOTE: During the study, use of these drugs will be discontinued.
    27. Subjects with Crohn’s Disease.
    28. Subjects with allergies or intolerance to 5-ASA
    29. Subjects with previous exposure to OPC-6535.
    30. Subjects taking prescription or over-the-counter anti-diarrheal agents within 3 days of the Screening Period.
    31. Subjects considered inappropriate by the Investigator for any reason(s).
    E.5 End points
    E.5.1Primary end point(s)
    Primary Outcome Variable:

    Efficacy: The primary efficacy measure is time to treatment failure, defined as (1) relapse of ulcerative colitis or (2) discontinuation from the study for any other reason. Relapse is defined as either (RB ≥ 1 and FS ≥ 1) or the need for other medication for treatment of an acute flare, as judged by the principal investigator. OPC-6535 25 mg QD and OPC-6535 50 mg QD will be compared to Asacol® 800 mg BID for non-inferiority and then for superiority—for a treatment duration of 26 weeks.

    Secondary Outcome Variables:

    Efficacy:
    1. Time to relapse (with non-relapse related discontinuations counted as censored data), with OPC-6535 25 mg QD and OPC-6535 50 mg QD compared to Asacol® 800 mg BID for non-inferiority and then for superiority—for a treatment duration of 26 weeks.

    2. Proportion of randomized subjects at Week 26 who are not treatment failures, with OPC-6535 25 mg QD and OPC-6535 50 mg QD compared to Asacol® 800 mg BID for non- inferiority and then for superiority.

    3. Time to treatment failure, with treatment failure defined as for the primary analysis, but with the OPC-6535 25 mg QD and OPC-6535 50 mg QD doses pooled together, compared to Asacol® 800 mg BID for non-inferiority and then for superiority—for a treatment duration of 26 weeks.

    4. Proportion of randomized subjects at Week 26 who are not treatment failures, with treatment failure defined as for the primary analysis, but with the OPC-6535 25 mg QD and OPC-6535 50 mg QD doses pooled together, compared to Asacol® 800 mg BID for non-inferiority and then for superiority—for a treatment duration of 26 weeks.

    5. Time to treatment failure, with treatment failure defined as for the primary
    analysis, with OPC-6535 25 mg QD and OPC-6535 50 mg QD compared to Asacol® 800 mg BID for non-inferiority and then for superiority—for a treatment duration of 52 weeks.

    6. Proportion of randomized subjects at Week 52 who are not treatment failures, with OPC-6535 25 mg QD and OPC-6535 50 mg QD compared to Asacol® 800 mg BID for non- inferiority and then for superiority.

    7. Proportion of randomized subjects at Week 52 who have experienced endoscopic relapse, defined as FS ≥ 1, with OPC-6535 25 mg QD and OPC-6535 50 mg QD compared to Asacol® 800 mg BID for non-inferiority and then for superiority.
    A flexible sigmoidoscopy may be triggered by a subject's rectal bleeding, but is also routinely scheduled in all subjects at Week 52 or upon early termination. For any flexible sigmoidoscopy, if inflammation is identified (FS >=1), endoscopic relapse will have occurred. Thus, subjects with endoscopic relapse may be either symptomatic (RB >=1) or asymptomatic (RB=0). Note, however, that asymptomatic endoscopic relapses are not counted as treatment failures.

    8. Change from baseline in health related quality of life at Weeks 26 and 52, based on the Inflammatory Bowel Disease Questionnaire (IBDQ), with OPC-6535 25 mg QD and OPC-6535 50 mg QD compared to Asacol® 800 mg BID.

    9. For each of the following categories, at Weeks 26 and 52, the proportion of randomized subjects who are not treatment failures will be reported for each treatment group:
    (a) No 5-ASA taken prior to time of randomization;
    (b) 5-ASA taken prior to time of randomization at a daily dose ≤ 1.6 g/day;
    (c) 5-ASA taken prior to time of randomization at a daily dose > 1.6 g/day.

    10. For each of the following categories, the times to treatment failure will be shown by plotting Kaplan-Meier curves for each treatment group:
    (a) No 5-ASA taken prior to time of randomization;
    (b) 5-ASA taken prior to time of randomization at a daily dose ≤ 1.6 g/day;
    (c) 5-ASA taken prior to time of randomization at a daily dose > 1.6 g/day.

    11. Changes from baseline in the stool frequency scores, bleeding scores, bowel urgency scores, abdominal pain scores and general well being scores recorded at Randomization, Weeks 1, 13, 26, 39, and 52, will be presented graphically by treatment group.

    Safety: Vital signs, ECGs, laboratory studies (including hematology, clinical chemistry, and urinalysis), and adverse events.

    Pharmacokinetics: OPC-6535 plasma concentrations.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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) Yes
    E.8.2.2Placebo No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 visit of last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 930
    F.4.2.2In the whole clinical trial 1725
    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 subject will received the expected normal treatment of such condition.
    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 Decision2004-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-10-19
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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