Status:
COMPLETED
A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis
Lead Sponsor:
Palau Pharma S.L.U.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00808977
Start Date
December 1 2008
End Date
June 1 2010
Last Update
November 17 2010
Active Locations (22)
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1
Investigational site 11
Kortrijk, Belgium
2
Investigational site 1
Leuven, Belgium
3
Investigational site 12
Budapest, Hungary
4
Investigational site 10
Eger, Hungary