At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 443 enrolled
Drug / intervention
Balsalazide Disodiumdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Open-label Trials to Evaluate the Long-term Safety and Tolerability of a New Balsalazide Disodium Tablet Formulation in Patients With Ulcerative Colitis
In Brief
A Phase 3 clinical trial evaluating Balsalazide Disodium for Inflammatory Bowel Disease and Ulcerative Colitis. Completed, enrolled 443 participants across 95 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInflammatory Bowel Disease, Ulcerative Colitis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2006
First PostedJun 2007
Primary CompletionApr 2008
Study CompletionDec 2008
TodayJul 2026
First PostedJun 13, 2007
Enrollment StartOct 1, 2006
Primary CompletionApr 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 19.1 years ago
Interventions
Balsalazide Disodiumdrug