Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis
Public ClinicalTrials.gov record NCT00151892. 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
A Phase III, Randomized Multi-centre, Double-blind, Parallel Group, Active Comparator Study to Compare the Efficacy and Safety of SPD476 (Mesalazine)2.4g/Day Once Daily With Asacol 1.6g/Day Twice Daily in the Maintenance of Remission in Patients With Ulcerative Colitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of the bowel becomes red and swollen. Over time, patients with this disease may experience acute episodes of diarrhea, rectal bleeding and abdominal pain followed by periods of time without disease symptoms. 5-ASA drugs are a standard treatment for ulcerative colitis. Mesalazine is an experimental drug designed to gradually release 5-ASA into the areas of large bowel associated with ulcerative colitis. This study will test the safety and efficacy of mesalazine in keeping ulcerative colitis in remission.
Study identification
- NCT ID
- NCT00151892
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 829 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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 8, 2005 (Actual)
- Primary completion
- Sep 7, 2009 (Actual)
- Completion
- Sep 7, 2009 (Actual)
- Last update posted
- Jun 14, 2021
2005 – 2009
United States locations
- U.S. sites
- 15
- U.S. states
- 13
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Gastroenterology Associates | Birmingham | Alabama | 35209 | — |
| Connecticut Gastroenterology Institute | Bristol | Connecticut | 06010 | — |
| Washington Gastroenterology | Washington D.C. | District of Columbia | 20010 | — |
| Southern Clinical Research Consultants | Hollywood | Florida | 33021 | — |
| Boorland-Groover Clinic | Jacksonville | Florida | 32256 | — |
| United Medical Research | New Smyrna Beach | Florida | 32168 | — |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30342 | — |
| Midwest Clinical Research Center | Moline | Illinois | 61265 | — |
| Gastrointestinal Clinic of Quad Cities | Davenport | Iowa | 52807 | — |
| Drug Research Services, Inc. | Metairie | Louisiana | 70006 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Center for Digestive and Liver Diseases, Inc | Mexico | Missouri | 65265 | — |
| New York Center for Clinical Research | Lake Success | New York | 11042 | — |
| ClinSearch | Chattanooga | Tennessee | 37404 | — |
| S D Khan | Houston | Texas | 77090 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 127 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00151892, 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 Jun 14, 2021 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00151892 live on ClinicalTrials.gov.