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

This study has been completed.
Information provided by:
Palau Pharma S.A.
ClinicalTrials.gov Identifier:
First received: December 15, 2008
Last updated: November 16, 2010
Last verified: November 2010

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.

Condition Intervention Phase
Ulcerative Colitis
Drug: Dersalazine sodium
Drug: Mesalazine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Palau Pharma S.A.:

Primary Outcome Measures:
  • Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal [ Time Frame: 7, 14, 21, 28, 56 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mayo index [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: December 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dersalazine Drug: Dersalazine sodium
Dersalazine sodium 2400 mg daily
Active Comparator: Mesalazine Drug: Mesalazine
Mesalazine 2400 mg daily
Placebo Comparator: Placebo Drug: Placebo
Placebo matching active and experimental treatments


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808977

Investigational site 11
Kortrijk, Belgium
Investigational site 1
Leuven, Belgium
Investigational site 12
Budapest, Hungary
Investigational site 10
Eger, Hungary
Investigational site 9
Miskolc, Hungary
Investigational site 8
Székesfehérvár, Hungary
Investigational site 7
Vác, Hungary
Investigational site 20
Košice, Slovakia
Investigational site 18
Košice, Slovakia
Investigational site 16
Malacky, Slovakia
Investigational site 17
Nové Zámky, Slovakia
Investigational site 19
Rožňava, Slovakia
Investigational site 2
Badalona, Spain
Investigational site 3
Barcelona, Spain
Investigational site 5
Barcelona, Spain
Investigational site 15
Barcelona, Spain
Investigational site 21
Cádiz, Spain
Investigational site 6
Córdoba, Spain
Investigational site 22
Madrid, Spain
Investigational site 14
Sabadell, Spain
Investigational site 13
Terrassa, Spain
Investigational site 4
Terrassa, Spain
Sponsors and Collaborators
Palau Pharma S.A.
Principal Investigator: Julian Panés, MD Hospital Clínic de Barcelona
  More Information

No publications provided by Palau Pharma S.A.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Caridad Pontes / Head Clinical Research, Palau Pharma S.A.
ClinicalTrials.gov Identifier: NCT00808977     History of Changes
Other Study ID Numbers: CR-IBD-1-08, EudraCT 2008-004610-27
Study First Received: December 15, 2008
Last Updated: November 16, 2010
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Spain: Spanish Agency of Medicines
Hungary: National Institute of Pharmacy
Slovakia: State Institute for Drug Control

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014