FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
Public ClinicalTrials.gov record NCT00064454. 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 II: 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
- NCT00064454
- 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
- Jun 30, 2006
- Completion
- Jun 30, 2006
- Last update posted
- May 9, 2012
2003 – 2006
United States locations
- U.S. sites
- 28
- U.S. states
- 21
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Redpoint Research | Phoenix | Arizona | 85029 | — |
| Desert Sun Gastroenterology | Tucson | Arizona | 85710 | — |
| Central California Medical Research | Fresno | California | 93720 | — |
| Rocky Mountain Clinical Research | Golden | Colorado | 80401 | — |
| Gastroenterology Associated of Fairfield County | Bridgeport | Connecticut | 06606 | — |
| Washington Fetterson, Washington Gastroenterology | Washington D.C. | District of Columbia | 20010 | — |
| Florida Medical Research Institute | Gainesville | Florida | 32605 | — |
| Mark Lamet | Hollywood | Florida | 33021 | — |
| Borland-Groover Clinic | Jacksonville | Florida | 32256 | — |
| Bruce Salzberg | Atlanta | Georgia | 30342 | — |
| Drug Research Services | Metairie | Louisiana | 70001 | — |
| Metropolitan Gastroenterology Group | Chevy Chase | Maryland | 20815 | — |
| Highland Medical Center | Braintree | Massachusetts | 02814 | — |
| Minnesota Gastroenterology | Plymouth | Minnesota | 55446 | — |
| Gastrointestial Associates, PA | Jackson | Mississippi | 39202 | — |
| Affiliates in Gastroeneterology | Florham Park | New Jersey | 07932 | — |
| Long Island Clinical Research Associates, LLP | Great Neck | New York | 11021 | — |
| Asheville Gastroenterology Associates | Asheville | North Carolina | 28801 | — |
| Charlotte Gastroenterology and Hepatology | Charlotte | North Carolina | 28207 | — |
| Carolina Research Center | Greenville | North Carolina | 27834 | — |
| Boice-Willis Clinic | Rocky Mount | North Carolina | 27804 | — |
| West Hills Gastroenterology Associates | Portland | Oregon | 97225 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Gastrointestinal Associates | Knoxville | Tennessee | 37909 | — |
| Nashville Medical Research Institute | Nashville | Tennessee | 37205 | — |
| System Endocrinology & Research Center | Houston | Texas | 77024 | — |
| Internal Medicine Associates | Danville | Virginia | 24541 | — |
| University of Wisconsin Medical School | Madison | Wisconsin | 53792 | — |
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 NCT00064454, 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 Jun 25, 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 NCT00064454 live on ClinicalTrials.gov.