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    The EU Clinical Trials Register currently displays   38179   clinical trials with a EudraCT protocol, of which   6271   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).
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    EudraCT Number:2005-003724-19
    Sponsor's Protocol Code Number:197-02-218
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2005-09-07
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2005-003724-19
    A.3Full title of the trial
    A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis
    A.3.2Name or abbreviated title of the trial where available
    197-02-218 Protocol
    A.4.1Sponsor's protocol code number197-02-218
    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.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 Coated 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.3.8INN - Proposed INNNot applicable
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeOPC-6535
    D.3.9.3Other descriptive nameOPC-6535
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 placeboCoated tablet
    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
    Active Ulcerative Colitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level LLT
    E.1.2Classification code 10058816
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To confirm the efficacy and safety profile seen in the phase II study of 25 mg and 50 mg once daily OPC-6535 oral tablets in the treatment of active ulcerative colitis.
    E.2.2Secondary objectives of the trial
    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 established diagnosis of active ulcerative colitis, who have relapsed within 12 weeks before screening. All subjects must have had the diagnosis of ulcerative colitis established by colonoscopy prior to randomization. (Newly diagnosed subjects are also eligible.) Colonoscopy may be substituted for flexible sigmoidoscopy during Screening in order to meet this criteria.
    3. Colonic involvement with ulcerative colitis beyond 15 cm of the anal verge.
    4. Subjects with a score ³ 2 for rectal bleeding and a score ³ 2 on flexible sigmoidoscopy at the Screening/Baseline Visit, based on the DAI criteria.
    5. Subjects who have been on a stable dose of oral 5-ASA for at least 14 days prior to the Screening/Baseline, OR subjects who have not been receiving treatment with 5-ASA for at least 14 days.
    6. 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/Baseline Visit through 30 (females) and 90 (males) days, respectively, from the last dose of study medication. Females who are more than 12 months post-menopausal (documented by FSH) are also eligible to participate in the study. [See Section 5.4 of the protocol for a description of acceptable forms of birth control.]
    E.4Principal exclusion criteria
    1. Subjects who have severe disease, defined as a DAI of 12 at the Screening/Baseline Visit, and/or subjects whom the Investigator deems likely to require immunosuppressant therapy including corticosteroids and/or hospitalization during the period of study
    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 corticosteroids (including oral budesonide) within 30 days, or topical intrarectal agents (corticosteroid or 5-ASA enemas, suppositories, foams) within 7 days of Screening/Baseline [Topical dermatological corticosteroids are not excluded]
    5. Subjects who have used immunosuppressants within 28 days or IL-10, IL-11, FK-506 [tacrolimus], mycophenolate, cyclosporin, anti-TNF-a or monoclonal antibody medications within 60 days of Screening/Baseline
    6. Subjects who have a history of active malignancies within 5 years (surgically-treated basal cell, squamous cell, non-melanoma 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 a known history of, or suspected, clinically relevant cardiac disease
    9. Subjects with a positive stool culture for any enteric pathogens, pathogenic ova or parasites, or a positive assay for C. difficile toxin (a positive EIA that is subsequently confirmed by a positive cytoxin assay)
    10. Subjects with partial bowel obstruction, as documented by proximal small bowel dilatation at Screening/Baseline
    11. Female subjects who are pregnant or lactating
    12. Female subjects who are likely to undergo an in vitro fertilization (IVF ) procedure from the Screening/Baseline Visit through 30 days after the last dose of study medication, OR male subjects likely to participate in an IVF procedure from the Screening/Baseline Visit through 90 days after the last dose of study medication
    13. 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
    14. Subjects with compromised renal function, characterized by serum creatinine levels 1.5 times the upper normal limit
    15. Subjects with a platelet count <100,000 or >750,000/mm3 based on clinical laboratory results
    16. Subjects with severe anemia, defined as hemoglobin of <8.0 g/dL based on clinical laboratory results
    17. Subjects with a serum albumin <2.5 g/dL based on clinical laboratory results
    18. Subjects with a prothrombin time INR > 1.2 based on clinical laboratory results
    19. Subjects with a neutrophil count of <2000/mm3 based on clinical laboratory results
    20. Subjects taking ³ 325 mg aspirin/day or chronic (³ 7 consecutive days) NSAID use within 7 days of Screening/Baseline
    21. Subjects who have used antibiotics, other than topical antibiotics for dermatological use, within 14 days of Screening/Baseline
    22. Subjects taking warfarin within 7 days of the Screening/Baseline Visit, or who are likely to take warfarin during the study
    23. Subjects taking CYP1A2 inducer medications (See Appendix 7 in the Protocol)
    24. Subjects taking pharmaceutical nicotine within 14 days of Screening/Baseline, or who are likely to take pharmaceutical nicotine during the study
    25. Subjects with a history of known or suspected alcohol or drug abuse within 6 months of Screening/Baseline
    26. Subjects taking prescription or over-the-counter anti-diarrheal agents, such as Lomotil® or Imodium®, within 3 days of Screening/Baseline
    27. Subjects who receive an experimental drug or procedure within 30 days of the Screening/Baseline Visit, or who are likely to receive an experimental drug or procedure during the study through the 30-day period after the final administration of study drug. [An experimental agent is defined as any compound assessed under an IND. All experimental agents with documented or potential immunosuppressive effects must be withdrawn 90 days prior to the first administration of study drug.]
    28. Subjects considered inappropriate by the Investigator for any reason(s)
    29. Subjects who have changed their 5-ASA dose or began taking 5-ASA within the 14 days prior to Screening/Baseline
    30. Subjects with Crohn’s Disease
    31. Subjects with previous exposure to OPC-6535
    32. Subjects who have taken COX-2 inhibitor medications (i.e., Celebrex®, Vioxx®) for ³ 7 consecutive days within 7 days of Screening/Baseline
    E.5 End points
    E.5.1Primary end point(s)
    Clinical improvement at week 8 based on the ITT population (denoted as clinical improvement (ITT)), with the restriction that subjects who drop out before completing the week 8 visit will be considered as not exhibiting clinical improvement, regardless of their Disease Activity Index (DAI) scores. Subjects who complete the Week 8 visit on or after day 52 from the date of randomisation (irrespective of whether or not they were still taking medication) and show clinical improvement (as defined below) will be counted as demonstrating clinical improvement (ITT).
    Clinical improvement is defined as a reduction from baseline in rectal bleading (RB) score of 2 or greater to a score of 0 or 1 plus an improvement of at least 1 point in one other subscale of the DAI: flexible sigmoidoscopy (FS), physician' global assessment (PGA), or stool frequency (SF). The primary efficacy comparisons are 25 mg OPC-6535 vs. placebo and 50 mg OPC-6535 vs. placebo stratified by 5-ASA (5-ASA users or non-users).
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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. 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 Yes
    E. trial design description
    stratified by 5-ASA users and non-users
    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.8.5The 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
    The end of study for each subject is the date on which the last evaluation (the follow-up phone call at Week 10) was performed or the attempt was made to contact the subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 months36
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-09-07. Yes
    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 110
    F.4.2.2In the whole clinical trial 375
    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 Decision2005-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-10-05
    P. End of Trial
    P.End of Trial StatusOngoing
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