Clinical trial

Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study

NCT00486031 · Bausch Health Americas, Inc., Industry · Completed

Key facts

NCT number NCT00486031
Title Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study
Official title A Multicenter, Open-label Trials to Evaluate the Long-term Safety and Tolerability of a New Balsalazide Disodium Tablet Formulation in Patients With 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 443
Start date Oct 1, 2006
Primary completion Apr 1, 2008
Completion Dec 1, 2008
First posted Jun 13, 2007
Last update posted Aug 15, 2019
Countries United States

At a glance

  • 10–99 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:

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