NCT00486031

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 443 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to evaluate the long-term safety and tolerability of treatment with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or who have mildly to moderately active UC.

Detailed description

The objective of the study is to evaluate the long-term safety and tolerability of treatment with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or who have mildly to moderately active UC.

Conditions

• Inflammatory Bowel Disease
• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Balsalazide Disodium

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-04-01
• Completion: 2008-12-01
• First posted: 2007-06-13
• Last updated: 2019-08-15
• Results posted: 2018-01-19

Locations

95 sites across 1 country: United States