Overview

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