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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00092508 |
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Date of registration:
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22/09/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission
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Scientific title:
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Phase 3, Multi-Center, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25 mg QD and 50 mg QD of OPC-6335 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Ulcerative Colitis Remission |
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Date of first enrolment:
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May 2004 |
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Target sample size:
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1725 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00092508 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female subjects, 18 to 80 years of age, inclusive.
- Subjects with a prior diagnosis of ulcerative colitis, established by colonoscopy.
- Subjects currently in remission.
- 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.
- 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.
- 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).
- 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.
Exclusion Criteria:
- Subjects who have active disease.
- Subjects who have any other clinically significant disease(s) or
condition/procedure(s).
- Subjects who have had major gastrointestinal surgery including, but not limited to, a
colostomy, an ileostomy or previous colonic surgery other than appendectomy.
- Subjects who have used corticosteroids or topical agents (corticosteroid or 5-ASA
enemas, suppositories, foams) within 6 weeks of the Screening Period.
- Female subjects who are pregnant or lactating.
- Other exclusion criteria may apply.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: Asacol®
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Drug: OPC-6535
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Secondary ID(s)
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197-02-220
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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