New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis
Completed
Bausch Health Americas, Inc.
Phase 3
2005-12-01
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.
New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis
Completed
Valeant Pharmaceuticals International, Inc.
Phase 3
2005-12-01
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.
Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis
Completed
Bausch Health Americas, Inc.
Phase 3
2006-05-01
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 6 weeks of therapy.
Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis
Completed
Valeant Pharmaceuticals International, Inc.
Phase 3
2006-05-01
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 6 weeks of therapy.
Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study
Completed
Bausch Health Americas, Inc.
Phase 3
2006-10-01
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.
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