At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 290 enrolled
Drug / intervention
MMX Mesalaminedrug
Likely dose
MMX Mesalamine 2.4gfrom 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 Phase IV, Multi-center, Open-label Study to Assess Clinical Recurrence Related to Compliance With Treatment With MMX Mesalamine 2.4g/Day Given Once Daily for the Maintenance of Quiescent Ulcerative Colitis (UC)
In Brief
A Phase 4 clinical trial evaluating MMX Mesalamine for Ulcerative Colitis. Completed, enrolled 290 participants across 62 sites.
Detailed Summary
To evaluate the percentage of subjects with clinical recurrence of UC at 6 months using MMX mesalamine once daily.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2007
Enrollment StartMay 2007
Primary CompletionAug 2009
TodayJul 2026
First PostedMar 13, 2007
Enrollment StartMay 1, 2007
Primary CompletionAug 17, 2009
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 19.3 years ago
Interventions
MMX Mesalaminedrug
MMX™ mesalamine 2.4g/day to 4.8g/day once-daily (QD) (two to four 1.2g tablets MMX™ mesalamine, dosed QD,respectively).