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Sponsored by: |
Otsuka Pharmaceutical Development & Commercialization, Inc. |
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Information provided by: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
ClinicalTrials.gov Identifier: | NCT00064441 |
The purpose of this study is to evaluate the safety and efficacy of the drug OPC-6535 compared to a placebo in patients with active Ulcerative Colitis.
Depending on their response, participants will be offered the investigational medication for up to one year after the study’s completion at select sites.
Condition | Intervention | Phase |
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Ulcerative Colitis |
Drug: OPC-6535 Tablets (drug) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | FACTS I: A Phase 3, Multicenter, 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 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Additional exclusion criteria apply.
Please see study Web site for additional information.
Study ID Numbers: | 197-02-217 |
Study First Received: | July 8, 2003 |
Last Updated: | January 31, 2006 |
ClinicalTrials.gov Identifier: | NCT00064441 |
Health Authority: | United States: Food and Drug Administration |
Ulcerative Colitis |
Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases Inflammatory Bowel Diseases |
Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |
Pathologic Processes |