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

Palau Pharma

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Placebo; Drug: Dersalazine sodium; Drug: Mesalazine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00808977

CR-IBD-1-08

EudraCT 2008-004610-27 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 3 patient groups, including a placebo group

Dersalazine

Experimental group

Treatment:

Drug: Dersalazine sodium

Mesalazine

Active Comparator group

Treatment:

Drug: Mesalazine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo