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

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

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Dersalazine sodium; Drug: Mesalazine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Kortrijk, Belgium
    • Investigational site 11
  • Leuven, Belgium
    • Investigational site 1
• Hungary
  • Budapest, Hungary
    • Investigational site 12
  • Eger, Hungary
    • Investigational site 10
  • Miskolc, Hungary
    • Investigational site 9
  • Székesfehérvár, Hungary
    • Investigational site 8
  • Vác, Hungary
    • Investigational site 7
• Slovakia
  • Košice, Slovakia
    • Investigational site 18
  • Košice, Slovakia
    • Investigational site 20
  • Malacky, Slovakia
    • Investigational Site 16
  • Nové Zámky, Slovakia
    • Investigational site 17
  • Rožňava, Slovakia
    • Investigational site 19
• Spain
  • Badalona, Spain
    • Investigational site 2
  • Barcelona, Spain
    • Investigational site 15
  • Barcelona, Spain
    • Investigational site 3
  • Barcelona, Spain
    • Investigational site 5
  • Cádiz, Spain
    • Investigational site 21
  • Córdoba, Spain
    • Investigational site 6
  • Madrid, Spain
    • Investigational site 22
  • Sabadell, Spain
    • Investigational site 14
  • Terrassa, Spain
    • Investigational site 13
  • Terrassa, Spain
    • Investigational site 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo matching active and experimental treatments
Experimental: Dersalazine	Drug: Dersalazine sodium; Dersalazine sodium 2400 mg daily
Active Comparator: Mesalazine	Drug: Mesalazine; Mesalazine 2400 mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal	7, 14, 21, 28, 56 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Mayo index	28 days

Collaborators and Investigators

• Sponsor: Palau Pharma S.A.
• Investigators: Principal Investigator: Julian Panés, MD, Hospital Clinic of Barcelona

Publications and helpful links

General Publications

• Pontes C, Vives R, Torres F, Panes 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.
• Roman J, Planell N, Lozano JJ, Aceituno M, Esteller M, Pontes C, Balsa D, Merlos M, Panes 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: December 15, 2008
• First Submitted That Met QC Criteria: December 15, 2008
• First Posted (Estimate): December 16, 2008

Study Record Updates

• Last Update Posted (Estimate): November 17, 2010
• Last Update Submitted That Met QC Criteria: November 16, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Mesalamine
• Other Study ID Numbers: CR-IBD-1-08; EudraCT 2008-004610-27 (Registry Identifier: Eudra CT)