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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00064454
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 375 participants
Conditions and interventions
Conditions
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
- May 2003 (Type not available)
- Primary completion
- Jul 2006 (Actual)
- Completion
- Jul 2006 (Actual)
- Last update posted
- May 10, 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 10, 2012 · Synced Oct 21, 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 public registry record, listed eligibility criteria, and available contact information for NCT00064454 live on ClinicalTrials.gov.