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NCT00151892 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 829
- Enrollment target
NCT00151892: Completed Phase 3 study, sponsored by Shire.
NCT00151892 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 829 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00151892, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 829 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Endoscopic remission is defined as an endoscopy score of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal \[intact vascular pattern; no friability or granulation\], 1 = mild \[erythema; decreased vascular pattern; minimal granularity\], 2 = moderate \[marked erythema; granularity; friability; absent vascular pattern; bleeding with minimal trauma; no ulcerations\], 3 = severe \[ulceration; spontaneous bleeding\].
Interventions
- DRUG SPD476
- DRUG Asacol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 829 participants |
| Start Date | 2005-04-08 |
| Est. Completion | 2009-09-07 |
| Phase | Phase 3 |
What the finished NCT00151892 record still lists
NCT00151892 is an interventional study that assigns participants to a tested intervention. The registered 829 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which SPD476 is the first listed.
NCT00151892 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00151892 about?
NCT00151892 is a clinical study titled "Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis". 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-...
What is the current status of trial NCT00151892?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 829 participants. The study started on 2005-04-08. Estimated completion is 2009-09-07.
What interventions are being tested in trial NCT00151892?
The interventions under investigation include: SPD476 (DRUG), Asacol (DRUG).
Who is sponsoring clinical trial NCT00151892?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00151892's enrollment target sits among peer trials
829 400th of 2000 higher than 1,601 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
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