Clinical trial
Efficacy and Safety of SPD476 in Maintaining Remission in Patients With…
NCT00151892 · Shire, Industry · Completed
Key facts
| NCT number | NCT00151892 |
|---|---|
| Title | Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis |
| 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 |
| Lead sponsor | Shire, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Intervention type | Drug |
| Interventions | SPD476, Asacol |
| Enrollment | 829 |
| Start date | Apr 8, 2005 |
| Primary completion | Sep 7, 2009 |
| Completion | Sep 7, 2009 |
| First posted | Sep 9, 2005 |
| Last update posted | Jun 14, 2021 |
| Countries | Argentina, Australia, Belgium, Brazil, Canada, Chile, Czechia, Denmark, France, Germany, Hungary, India and 16 more |
At a glance
- 100–999 Study sites
- Yes 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: