Trials / Completed
CompletedNCT00151944
Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.
A Phase III, Randomized, Multi-center, Open-label, 12 to 14 Month Extension Study to Evaluate the Safety and Tolerability of SPD476 (Mesalazine) Given Once Daily vs. Twice Daily for the Maintenance of Ulcerative Colitis in Remission.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (planned)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SPD476 (mesalazine) |
Timeline
- Start date
- 2003-11-26
- Primary completion
- 2006-03-13
- Completion
- 2006-03-13
- First posted
- 2005-09-09
- Last updated
- 2021-06-23
Source: ClinicalTrials.gov record NCT00151944. Inclusion in this directory is not an endorsement.