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NCT00092508 · ClinicalTrials.gov registry record · Phase 3
CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,725
- Enrollment target
NCT00092508: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT00092508 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 1,725 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (123% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00092508, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,725 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG OPC-6535
- DRUG Asacol®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,725 participants |
| Start Date | 2004-05 |
| Est. Completion | 2007-05 |
| Phase | Phase 3 |
What the finished NCT00092508 record still lists
NCT00092508 is an interventional study that assigns participants to a tested intervention. Its 1,725 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (123% higher).
The record links to 0 conditions, and to 2 interventions - of which OPC-6535 is the first listed.
NCT00092508 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00092508 about?
NCT00092508 is a clinical study titled "CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission". 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.
What is the current status of trial NCT00092508?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,725 participants. The study started on 2004-05. Estimated completion is 2007-05.
What interventions are being tested in trial NCT00092508?
The interventions under investigation include: OPC-6535 (DRUG), Asacol® (DRUG).
Who is sponsoring clinical trial NCT00092508?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00092508's enrollment target sits among peer trials
1,725 130th of 2000 higher than 1,871 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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