FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
Public ClinicalTrials.gov record NCT00064441. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
FACTS I: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects With Active Ulcerative Colitis
Study identification
- NCT ID
- NCT00064441
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Industry
- Enrollment
- 375 participants
Conditions and interventions
Conditions
Interventions
- OPC-6535 Tablets (drug) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2003
- Primary completion
- Apr 30, 2006
- Completion
- Apr 30, 2006
- Last update posted
- May 9, 2012
2003 – 2006
United States locations
- U.S. sites
- 23
- U.S. states
- 14
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ascent Clinical Research | Scottsdale | Arizona | 85258 | — |
| West Gastroenterology Medical Group | Los Angeles | California | 90045 | — |
| Lovelace Scientific Resources | Santa Ana | California | 92704 | — |
| Western States Clinical Research, Inc. | Wheat Ridge | Colorado | 80033 | — |
| Lovelace Scientific Resources Florida | Miami | Florida | 33156 | — |
| Miami Research Associates | Miami | Florida | 33173 | — |
| Venture Research Institute LLC | North Miami Beach | Florida | 33162 | — |
| Gastroenterology Consultants, P.A. | Ormond Beach | Florida | 32174 | — |
| Gastroenterology Associates, LLC | Baton Rouge | Louisiana | 70809 | — |
| Digestive Disorders Associates | Annapolis | Maryland | 21401 | — |
| Digestive Disease Associates | Baltimore | Maryland | 21229 | — |
| Upstate Gastroenterology Associates | Troy | New York | 12180 | — |
| Bethany Medical Center | High Point | North Carolina | 27262 | — |
| Hanover Medical Specialists, P.A. | Wilmington | North Carolina | 28401 | — |
| Akron Gastroenterology Associates, Inc. | Akron | Ohio | — | — |
| Consultants for Clinical Research | Cincinnati | Ohio | 45219 | — |
| Gastrointestinal and Liver Diseases Consultants | Dayton | Ohio | 45440 | — |
| Sooner Clinical Reserach | Oklahoma City | Oklahoma | 73112 | — |
| Columbia Gastroenterology Associates | Columbia | South Carolina | 29203 | — |
| Memphis Gastroenterology Group, PC | Memphis | Tennessee | 38120 | — |
| Digestive Associates of Houston | Houston | Texas | 77030 | — |
| Houston Digestive Diseases Clinic | Houston | Texas | 77090 | — |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00064441, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 9, 2012 · Synced May 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00064441 live on ClinicalTrials.gov.