At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 51 enrolled
Drug / intervention
High dose +2 moredrug
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 Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients With Active, Mild to Moderate Ulcerative Colitis
In Brief
A Phase 2 clinical trial evaluating High dose, Low dose, and 1 other intervention for Colitis, Ulcerative. Completed, enrolled 51 participants across 1 site.
Detailed Summary
IBD98-M-2002 is a phase 2a , Randomized, Double blind, Placebo-controlled of IBD98-M Delayed Release capsules in subjects with Mild to Moderately Ulcerative Colitis to investigate the clinical efficacy of IBD98-M delayed release capsules (in a fixed combination) over a 6-week treatment period and 2 weeks follow up.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColitis, Ulcerative
CountriesItaly
CollaboratorsinVentiv Health Clinical
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 2015
Enrollment StartJan 2016
Primary CompletionJul 2018
Study CompletionApr 2019
TodayJul 2026
First PostedJul 9, 2015
Enrollment StartJan 1, 2016
Primary CompletionJul 1, 2018
Study CompletionApr 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.0 years ago
Interventions
High dosedrug
6 capsules of IBD98-M, twice a day
Low dosedrug
4 capsules of IBD98-M
Placebodrug
Placebo