At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 80 target
Drug / intervention
Dersalazine sodium +2 moredrug
Likely dose
Dersalazine sodium 2400 mgfrom 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 Double-blind, Randomised, Placebo and Mesalazine Controlled Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Active Colitis
In Brief
A Phase 2 clinical trial evaluating Dersalazine sodium, Mesalazine, and 1 other intervention for Ulcerative Colitis. Completed, enrolled 80 participants across 22 sites in 4 countries.
Detailed Summary
The purpose of the study is to obtain a first clinical assessment of the safety of dersalazine sodium in ulcerative colitis patients with mild to moderate disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesBelgium, Hungary, Slovakia, Spain
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2008
First PostedDec 2008
Primary CompletionJun 2010
TodayJul 2026
First PostedDec 16, 2008
Enrollment StartDec 1, 2008
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.5 years ago
Interventions
Dersalazine sodiumdrug
Dersalazine sodium 2400 mg daily
Mesalazinedrug
Mesalazine 2400 mg daily
Placebodrug
Placebo matching active and experimental treatments