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NCT00064441 · ClinicalTrials.gov registry record · Phase 3
FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 375
- Enrollment target
NCT00064441 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 375 participants.
The verdict
NCT00064441, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 375 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG OPC-6535 Tablets (drug)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 375 participants |
| Start Date | 2003-05 |
| Est. Completion | 2006-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00064441
The ClinicalTrials.gov registry entry for NCT00064441 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 375 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 1 intervention - of which OPC-6535 Tablets (drug) is the first listed.
NCT00064441 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00064441 about?
NCT00064441 is a clinical study titled "FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis". 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 ...
What is the current status of trial NCT00064441?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 375 participants. The study started on 2003-05. Estimated completion is 2006-05.
What interventions are being tested in trial NCT00064441?
The interventions under investigation include: OPC-6535 Tablets (drug) (DRUG).
Who is sponsoring clinical trial NCT00064441?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
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