New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): 5 ASA, enemas, suppositories, corticosteroids
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment