Clinical trial
Safety and Tolerability of SPD476 in Maintaining Remission in Patients With…
NCT00151944 · Shire, Industry · Completed
Key facts
| NCT number | NCT00151944 |
|---|---|
| Title | Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis. |
| Official title | 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. |
| Lead sponsor | Shire, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Colitis, Ulcerative |
| Intervention type | Drug |
| Interventions | SPD476 (mesalazine) |
| Enrollment | 400 |
| Start date | Nov 26, 2003 |
| Primary completion | Mar 13, 2006 |
| Completion | Mar 13, 2006 |
| First posted | Sep 9, 2005 |
| Last update posted | Jun 23, 2021 |
At a glance
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: