NCT00269438

New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 225 (planned)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is 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.

Detailed description

The primary efficacy endpoint is the proportion of subjects that achieve clinical improvement and improvement in the rectal bleeding subscale of the MMDAI at the end of eight weeks of therapy, where clinical improvement is defined as a greater than or equal to 3 point improvement from baseline in the MMDAI. The secondary endpoints are as follows: 1. The change from baseline over the duration of treatment in total MMDAI score and in the individual MMDAI subscales. 2. The change from baseline to Weeks 1, 2, 4 and 8 in total MMDAI score and in each individual MMDAI subscale (endoscopy/sigmoidoscopy at Weeks 2 and 8 only). 3. The proportion of subjects with treatment failure, defined as withdrawal due to significant disease progression or lack of significant improvement, as determined by the Investigator. 4. The proportion of subjects with mucosal healing at Weeks 2 and 8, where mucosal healing is defined as an endoscopy/sigmoidoscopy score of 0 or 1 5. The proportion of subjects achieving complete remission at Week 2 and Week 8, where complete remission is defined as a MMDAI score of less than or equal to 1. 6. The proportion of subjects with improvement from baseline to Weeks 1, 2, 4 and 8 in total MMDAI score and in each individual MMDAI subscale (endoscopy/sigmoidoscopy at Weeks 2 and 8 only). 7. Change from baseline to Weeks 1, 2, 4 and 8 in diarrhea, abdominal discomfort, and subjective sense of well being, as recorded in the subjects' diaries. 8. The proportion of subjects achieving clinical remission at Weeks 1, 2, 4 and 8, where clinical remission is defined as a score of 0 for rectal bleeding and a combined score of less than or equal to 2 for bowel frequency and physician assessment using the MMDAI. 9. Time to clinical remission, where clinical remission is defined as in secondary endpoint number eight. Safety endpoints are as follows: * incidence of treatment-emergent AEs grouped by body system and evaluated by treatment group; * changes from baseline in clinical laboratory parameters at each treatment visit by treatment group; and * changes from baseline in vital sign measurements at each treatment visit by treatment group.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	5 ASA, enemas, suppositories, corticosteroids

Timeline

• Start date: 2005-12-01
• Primary completion: 2007-03-01
• Completion: 2007-06-01
• First posted: 2005-12-23
• Last updated: 2019-11-25

Locations

66 sites across 1 country: United States