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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.
Sponsor:
Information provided by:
Palau Pharma S.A.
ClinicalTrials.gov Identifier:
NCT00808977
First received: December 15, 2008
Last updated: November 16, 2010
Last verified: November 2010
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Belgium
Investigational site 11
Kortrijk, Belgium
Investigational site 1
Leuven, Belgium
Hungary
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
Slovakia
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
Spain
Investigational site 2
Badalona, Spain
Investigational site 5
Barcelona, Spain
Investigational site 15
Barcelona, Spain
Investigational site 3
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.
Investigators
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
Colitis, Ulcerative
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes
Mesalamine
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014