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NCT00064454 · ClinicalTrials.gov registry record · Phase 3
FACTS II: 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
NCT00064454: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT00064454 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 375 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00064454, 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 | 2006-07 |
| Phase | Phase 3 |
What the finished NCT00064454 record still lists
NCT00064454 is an interventional study that assigns participants to a tested intervention. The registered 375 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 1 intervention - of which OPC-6535 Tablets (drug) is the first listed.
NCT00064454 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00064454 about?
NCT00064454 is a clinical study titled "FACTS II: 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 NCT00064454?
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 2006-07.
What interventions are being tested in trial NCT00064454?
The interventions under investigation include: OPC-6535 Tablets (drug) (DRUG).
Who is sponsoring clinical trial NCT00064454?
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 NCT00064454's enrollment target sits among peer trials
375 988th of 2000 higher than 1,010 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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