CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission
Public ClinicalTrials.gov record NCT00092508. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT00092508
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Industry
- Enrollment
- 1,725 participants
Conditions and interventions
Conditions
Interventions
- OPC-6535 Drug
- Asacol® Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2004
- Primary completion
- Not listed
- Completion
- Apr 30, 2007
- Last update posted
- Jun 20, 2007
2004 – 2007
United States locations
- U.S. sites
- 26
- U.S. states
- 18
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Associates | Huntsville | Alabama | 35801 | — |
| West Gastroenterology Medical Group | Los Angeles | California | 90045 | — |
| Mark Lamet | Hollywood | Florida | 33021 | — |
| Borland-Groover Clinic | Jacksonville | Florida | 32256 | — |
| Advanced Gastroenterology Associates | Palm Harbor | Florida | 34684 | — |
| Florida Medical Clinic | Zephyrhills | Florida | 33542 | — |
| Digestive Disorders Associates | Annapolis | Maryland | 21404 | — |
| Metropolitan Gastroenterology Group | Chevy Cha | Maryland | 20815 | — |
| Coastal Research Associates | Braintree | Massachusetts | 02184 | — |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | — |
| Digestive Health Specialists, PA | Tupelo | Mississippi | 38801 | — |
| Center for Digestive and Liver Diseases | Mexico | Missouri | 65265 | — |
| Atlantic Gastroenterology Associates, PA | Egg Harbor | New Jersey | 08234 | — |
| Long Island Clinical Research Associates | Great Neck | New York | 11021 | — |
| Asheville Gastroenterology Associates | Asheville | North Carolina | 28801 | — |
| Charlotte Gastroenterology & Hepatology | Charlotte | North Carolina | 28207 | — |
| Bethany Medical Center | High Point | North Carolina | 27262 | — |
| Hanover Medical Specialists, PA | Wilmington | North Carolina | 28401 | — |
| GI & Liver Consultants | Dayton | Ohio | 45440 | — |
| Sooner Clinical Research | Oklahoma City | Oklahoma | 73112 | — |
| Healthcare Research Consultants | Tulsa | Oklahoma | 74135 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Gastroenterology Associates | Kingsport | Tennessee | 37660 | — |
| Gastroenterology Clinic of San Antonio | San Antonio | Texas | 78229 | — |
| Advanced Research Institute | Ogden | Utah | 84405 | — |
| McGuire DVAMC | Richmond | Virginia | 23149 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00092508, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 20, 2007 · Synced Jul 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00092508 live on ClinicalTrials.gov.