Last reviewed · How we verify
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
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.
Details
| Lead sponsor | Palau Pharma S.L.U. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 80 |
| Start date | 2008-12 |
| Completion | 2010-06 |
Conditions
- Ulcerative Colitis
Interventions
- Dersalazine sodium
- Mesalazine
- Placebo
Primary outcomes
- Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal — 7, 14, 21, 28, 56 days
Countries
Belgium, Hungary, Slovakia, Spain