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Sponsored by: |
Salix Pharmaceuticals |
Information provided by: | Salix Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00408174 |
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.
Condition | Intervention | Phase |
Inflammatory Bowel Disease Ulcerative Colitis |
Drug: Balsalazide disodium |
Phase III |
Genetics Home Reference related topics: | Crohn disease |
MedlinePlus related topics: | Ulcerative Colitis |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Actively-Controlled Trial to Evaluate the Safety and Efficacy of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium 3.3 g Bid Versus Mesalamine (5-ASA) as Asacol® 0.8 g Tid in Mildly to Moderately Active Ulcerative Colitis |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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Show 88 Study Locations |
Salix Pharmaceuticals |
Study ID Numbers: | BZUC3003 |
First Received: | December 4, 2006 |
Last Updated: | December 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00408174 |
Health Authority: | United States: Food and Drug Administration |
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