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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This dose comparison study, taking place at over 200 sites worldwide, will compare the dosing, safety and efficacy of an investigational medicine OPC-6535 to the dosing, safety and efficacy of Asacol ® in the maintenance of remission in subjects with ulcerative colitis.
Study identification
- NCT ID
- NCT00092508
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,725 participants
Conditions and interventions
Conditions
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
- May 2004 (Type not available)
- Primary completion
- Not listed
- Completion
- May 2007 (Type not available)
- Last update posted
- Jun 21, 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 21, 2007 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00092508 live on ClinicalTrials.gov.