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

Recruiting in Palo Alto (17 mi)

+94 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Bausch Health Americas, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

Inclusion Criteria

Subject has a documented history of UC and is either in remission or currently presents with mildly to moderately active UC symptoms as determined by the investigator upon subject interview of UC symptoms, (e.g., urgency, bowel frequency, and rectal bleeding). Additionally, the diagnosis of UC must be confirmed by past flexible sigmoidoscopy/colonoscopy which may include colonic mucosal pathological findings on biopsy consistent with UC.

Subject is capable and willing to comply with all study procedures.