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

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:

Genetics Home Reference related topics: ulcerative colitis

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Mesalamine Mesalamine hydrochloride

U.S. FDA Resources

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 (Adult)
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 18
Košice, Slovakia
Investigational site 20
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 15
Barcelona, Spain
Investigational site 3
Barcelona, Spain
Investigational site 5
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pontes C, Vives R, Torres F, Panés J. Safety and activity of dersalazine sodium in patients with mild-to-moderate active colitis: double-blind randomized proof of concept study. Inflamm Bowel Dis. 2014 Nov;20(11):2004-12. doi: 10.1097/MIB.0000000000000166.

Román J, Planell N, Lozano JJ, Aceituno M, Esteller M, Pontes C, Balsa D, Merlos M, Panés J, Salas A. Evaluation of responsive gene expression as a sensitive and specific biomarker in patients with ulcerative colitis. Inflamm Bowel Dis. 2013 Feb;19(2):221-9. doi: 10.1002/ibd.23020.


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 Ulcer Colitis, Ulcerative Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases	Mesalamine Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents

ClinicalTrials.gov processed this record on September 23, 2016