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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00808977
Recruitment Status : Completed
First Posted : December 16, 2008
Last Update Posted : November 17, 2010
Sponsor:
Information provided by:
Palau Pharma S.A.

Study Description
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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

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Arms and Interventions
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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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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00808977


Locations
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Sponsors and Collaborators
Palau Pharma S.A.
Investigators
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Principal Investigator: Julian Panés, MD Hospital Clinic of Barcelona
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Caridad Pontes / Head Clinical Research, Palau Pharma S.A.
ClinicalTrials.gov Identifier: NCT00808977    
Other Study ID Numbers: CR-IBD-1-08
EudraCT 2008-004610-27 ( Registry Identifier: Eudra CT )
First Posted: December 16, 2008    Key Record Dates
Last Update Posted: November 17, 2010
Last Verified: November 2010
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
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