Clinical trial
Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative…
NCT00408174 · Bausch Health Americas, Inc., Industry · Completed
Key facts
| NCT number | NCT00408174 |
|---|---|
| Title | Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis |
| Official title | A Multicenter, Randomized, Double-Blind, Actively-Controlled Trial to Evaluate the Safety and Efficacy of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium 3.3 g Bid Versus Mesalamine (5-ASA) as Asacol® 0.8 g Tid in Mildly to Moderately Active Ulcerative Colitis |
| Lead sponsor | Bausch Health Americas, Inc., Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Disease, Ulcerative Colitis |
| Intervention type | Drug |
| Interventions | Balsalazide disodium |
| Enrollment | 400 |
| Start date | May 1, 2006 |
| Primary completion | Jul 1, 2007 |
| Completion | Nov 1, 2007 |
| First posted | Dec 6, 2006 |
| Last update posted | Nov 25, 2019 |
| Countries | United States |
At a glance
- 10–99 Study sites
- 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: