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

This study is not yet open for participant recruitment.

Verified by Palau Pharma S.A., December 2008

Sponsored by:	Palau Pharma S.A.
Information provided by:	Palau Pharma S.A.
ClinicalTrials.gov Identifier:	NCT00808977

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 II

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Dietary Sodium Ulcerative Colitis

Drug Information available for: Mesalamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
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

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
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Dersalazine: Experimental	Drug: Dersalazine sodium Dersalazine sodium 2400 mg daily
Mesalazine: Active Comparator	Drug: Mesalazine Mesalazine 2400 mg daily
Placebo: Placebo Comparator	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

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

Contacts

Contact: Caridad Pontes, MD, PhD	+34938630304	cpontes@palaupharma.com
Contact: Maria Sarasa, PhD	+34938630330	msarasa@palaupharma.com

Sponsors and Collaborators

Palau Pharma S.A.

Investigators

Principal Investigator:

Julian Panés, MD

Hospital Clínic de Barcelona

More Information

Responsible Party:	Palau Pharma S.A. ( Caridad Pontes / Head Clinical Research )
Study ID Numbers:	CR-IBD-1-08, EudraCT 2008-004610-27
Study First Received:	December 15, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00808977
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products; Belgium: Institutional Review Board; Spain: Comité Ético de Investigación Clínica; Spain: Spanish Agency of Medicines

Study placed in the following topic categories:

Digestive System Diseases
Mesalamine
Gastrointestinal Diseases
Ulcer
Colonic Diseases

Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Pathologic Processes
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs

Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009