Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT00064441 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
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 |
What the finished NCT00064441 record still lists
NCT00064441 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.
NCT00064441 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00064441'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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03686124 · 375 participants · Phase 1
ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors
- NCT04059172 · 375 participants · Early Phase 1
Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain Management
- NCT04134923 · 375 participants
Imaging Biomarkers in Preclinical and Symptomatic AD
- NCT04569747 · 375 participants · Phase 2
A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia