FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00064441|
Recruitment Status : Completed
First Posted : July 10, 2003
Last Update Posted : May 10, 2012
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 or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: OPC-6535 Tablets (drug)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||375 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||May 2003|
|Actual Primary Completion Date :||May 2006|
|Actual Study Completion Date :||May 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00064441