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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 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 1,725 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00092508
The ClinicalTrials.gov registry entry for NCT00092508 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,725 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which OPC-6535 is the first listed.
NCT00092508 reports 0 study locations.
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.
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