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

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dersalazine sodium
Mesalazine
Placebo
Sponsored by
Palau Pharma S.L.U.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigational site 11
  • Investigational site 1
  • Investigational site 12
  • Investigational site 10
  • Investigational site 9
  • Investigational site 8
  • Investigational site 7
  • Investigational site 18
  • Investigational site 20
  • Investigational site 16
  • Investigational site 17
  • Investigational site 19
  • Investigational site 2
  • Investigational site 15
  • Investigational site 3
  • Investigational site 5
  • Investigational site 21
  • Investigational site 6
  • Investigational site 22
  • Investigational site 14
  • Investigational site 13
  • Investigational site 4

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Dersalazine

Mesalazine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal

Secondary Outcome Measures

Mayo index

Full Information

First Posted
December 15, 2008
Last Updated
November 16, 2010
Sponsor
Palau Pharma S.L.U.
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1. Study Identification

Unique Protocol Identification Number
NCT00808977
Brief Title
A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis
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 Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Palau Pharma S.L.U.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dersalazine
Arm Type
Experimental
Arm Title
Mesalazine
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dersalazine sodium
Intervention Description
Dersalazine sodium 2400 mg daily
Intervention Type
Drug
Intervention Name(s)
Mesalazine
Intervention Description
Mesalazine 2400 mg daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching active and experimental treatments
Primary Outcome Measure Information:
Title
Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal
Time Frame
7, 14, 21, 28, 56 days
Secondary Outcome Measure Information:
Title
Mayo index
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian Panés, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Investigational site 11
City
Kortrijk
Country
Belgium
Facility Name
Investigational site 1
City
Leuven
Country
Belgium
Facility Name
Investigational site 12
City
Budapest
Country
Hungary
Facility Name
Investigational site 10
City
Eger
Country
Hungary
Facility Name
Investigational site 9
City
Miskolc
Country
Hungary
Facility Name
Investigational site 8
City
Székesfehérvár
Country
Hungary
Facility Name
Investigational site 7
City
Vác
Country
Hungary
Facility Name
Investigational site 18
City
Košice
Country
Slovakia
Facility Name
Investigational site 20
City
Košice
Country
Slovakia
Facility Name
Investigational site 16
City
Malacky
Country
Slovakia
Facility Name
Investigational site 17
City
Nové Zámky
Country
Slovakia
Facility Name
Investigational site 19
City
Rožňava
Country
Slovakia
Facility Name
Investigational site 2
City
Badalona
Country
Spain
Facility Name
Investigational site 15
City
Barcelona
Country
Spain
Facility Name
Investigational site 3
City
Barcelona
Country
Spain
Facility Name
Investigational site 5
City
Barcelona
Country
Spain
Facility Name
Investigational site 21
City
Cádiz
Country
Spain
Facility Name
Investigational site 6
City
Córdoba
Country
Spain
Facility Name
Investigational site 22
City
Madrid
Country
Spain
Facility Name
Investigational site 14
City
Sabadell
Country
Spain
Facility Name
Investigational site 13
City
Terrassa
Country
Spain
Facility Name
Investigational site 4
City
Terrassa
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25192498
Citation
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.
Results Reference
derived
PubMed Identifier
22605655
Citation
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.
Results Reference
derived

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

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