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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 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 829 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00151892
The ClinicalTrials.gov registry entry for NCT00151892 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 829 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which SPD476 is the first listed.
NCT00151892 reports 0 study locations.
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.
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