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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Palau Pharma S.A.
• Treatments: Mesalamine

Criteria

Inclusion Criteria:

• Age 18 to 65 inclusive

• Male, non-child-bearing female or fertile female with appropriate contraception.

• Mild to moderate confirmed active ulcerative colitis

• Able and willing to give informed consent

Exclusion Criteria:

• Colitis of other cause

• Pregnancy, inadequate contraception for fertile female patients

• Liver or kidney disease, unstable cardiovascular disease, coagulation disorder.

• Other significant medical condition that preclude participation at investigator criteria

• Allergy or hypersensitivity to salicylates

• Previous or concomitant treatment for ulcerative colitis interfering with safety or activity assessments