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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Ulcerative Colitis	Drug: Dersalazine sodium; Drug: Mesalazine; Drug: Placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	80 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, 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
Study Start Date :	December 2008
Actual Primary Completion Date :	June 2010
Actual Study Completion Date :	June 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal [ Time Frame: 7, 14, 21, 28, 56 days ]

Secondary Outcome Measures :

1. Mayo index [ Time Frame: 28 days ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 ( Registry Identifier: Eudra CT )
First Posted:	December 16, 2008
Last Update Posted:	November 17, 2010
Last Verified:	November 2010

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