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

Phase 3

Completed

• Conditions: Ulcerative Colitis; Inflammatory Bowel Disease
• Interventions: Drug: Balsalazide Disodium

• Registration Number: NCT00486031
• Lead Sponsor: Bausch Health Americas, Inc.

Brief 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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-06-11
• Study First Submitted QC: 2007-06-11
• Study First Posted: 2007-06-13
• Primary Completion: 2008-04
• Study Completion: 2008-12
• Results First Submitted: 2017-12-19
• Results First Submitted QC: 2017-12-19
• Results First Posted: 2018-01-19
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-01
• Last Update Posted: 2019-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 443

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.

Exclusion Criteria

• Subject has a history of allergy or intolerance to aspirin, mesalamine or other salicylates.
• Subject has participated in an investigational drug or device study, other than a previous balsalazide disodium tablet trial (i.e., BZUC3002 or BZUC3003), within 30 days of entering the current study.
• Subject discontinued from a previous balsalazide disodium tablet study due to study drug-related AE(s), including UC flare or associated symptoms that were perceived by the subject/investigator as being caused by study drug.
• Subject has had any prior bowel surgery, except appendectomy and cholecystectomy.
• Subject has unstable cardiovascular, coagulopathy, or pulmonary disease.
• Regular use of nonsteroidal anti-inflammatory drugs (NSAIDS) except cardioprotective ASA (i.e., less than or equal to 162 mg ASA per day).
• Subject has a history of human immunodeficiency virus (HIV) or hepatitis (B and C). Subjects with a history of hepatitis B and C will be eligible provided the screening LFTs are within normal limits.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
balsalazide disodium tablets,3.3 g BID,	Balsalazide Disodium	-

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment Emergent AEs	24 Months	Incidence of treatment emergent adverse events

Secondary Outcome Measures

Name	Time	Method
Time to Onset of AEs	24 Months	Time to onset of adverse events

Trial Locations

Locations (94)

Birmingham Gastroenterology Associates, PC; 🇺🇸 Birmingham, Alabama, United States

Premeire Pharmaceutical Research; 🇺🇸 Tempe, Arizona, United States

Medical Services of NWA; 🇺🇸 Fayetteville, Arkansas, United States

AGMG Clinical Research Institute; 🇺🇸 Anaheim, California, United States

Discovery Clinical Research, Inc.; 🇺🇸 Encinitas, California, United States

Digestive and Liver Disease Specialists; 🇺🇸 Norfolk, Virginia, United States

West Gastroenterology Medical Group; 🇺🇸 Los Angeles, California, United States

Community Clinical Trials; 🇺🇸 Orange, California, United States

Sharp Rees-Stealy Medical; 🇺🇸 San Diego, California, United States

Rocky Mountain Gastroenterology; 🇺🇸 Lakewood, Colorado, United States

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