A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis
This study has been completed.
Sponsor:
Palau Pharma S.A.
Information provided by:
Palau Pharma S.A.
ClinicalTrials.gov Identifier:
NCT00808977
First received: December 15, 2008
Last updated: November 16, 2010
Last verified: November 2010
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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
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 |
| 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
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 20 | |
| Košice, Slovakia | |
| Investigational site 18 | |
| 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 3 | |
| Barcelona, Spain | |
| Investigational site 5 | |
| Barcelona, Spain | |
| Investigational site 15 | |
| 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
No publications provided
| 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 Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Inflammatory Bowel Diseases Pathologic Processes Mesalamine |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013