Trial | NCT00808977  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    80
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 Started
Dec 31
2008
Primary Completion
Jun 30
2010
Study Completion
Jun 30
2010
Last Update
Nov 17
2010
Estimate

Drug Dersalazine sodium

Dersalazine sodium 2400 mg daily

Drug Mesalazine

Mesalazine 2400 mg daily

Drug Placebo

Placebo matching active and experimental treatments

Placebo Placebo Comparator

Dersalazine Experimental

Mesalazine Active Comparator

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
No Results Posted