Clinical trial
New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to…
NCT00269438 · Bausch Health Americas, Inc., Industry · Completed
Key facts
| NCT number | NCT00269438 |
|---|---|
| Title | New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis |
| Official title | Phase 3 Study to Establish the Efficacy and Safety of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium Dosed Twice Daily in Achieving Clinical Improvement in Subjects With Mildly to Moderately Active Ulcerative Colitis After 8 Weeks of Therapy |
| Lead sponsor | Bausch Health Americas, Inc., Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Intervention type | Drug |
| Interventions | 5 ASA, enemas, suppositories, corticosteroids |
| Enrollment | 225 |
| Start date | Dec 1, 2005 |
| Primary completion | Mar 1, 2007 |
| Completion | Jun 1, 2007 |
| First posted | Dec 23, 2005 |
| 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: