NCT00808977

A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Palau Pharma S.L.U. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Dersalazine sodium	Dersalazine sodium 2400 mg daily
DRUG	Mesalazine	Mesalazine 2400 mg daily
DRUG	Placebo	Placebo matching active and experimental treatments

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2008-12-16
• Last updated: 2010-11-17

Locations

22 sites across 4 countries: Belgium, Hungary, Slovakia, Spain