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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 (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 |
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 ]
Secondary Outcome Measures:
- Mayo index [ Time Frame: 28 days ]
| 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 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808977
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 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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 ) |
| Study First Received: | December 15, 2008 |
| Last Updated: | November 16, 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 |
ClinicalTrials.gov processed this record on August 16, 2017