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Completed

NCT Number: NCT00808977

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

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational site 11, Kortrijk, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dersalazine sodium

Drug

Dersalazine sodium 2400 mg daily

Mesalazine

Drug

Mesalazine 2400 mg daily

Placebo

Drug

Placebo matching active and experimental treatments

Primary outcomes

  1. Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal

    Time frame: 7, 14, 21, 28, 56 days

Secondary outcomes

  1. Mayo index

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Palau Pharma S.L.U.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 16, 2008
Registry last updated
Nov 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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