A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis
NCT ID: NCT00808977
Last Updated: 2010-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2008-12-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dersalazine
Dersalazine sodium
Dersalazine sodium 2400 mg daily
Mesalazine
Mesalazine
Mesalazine 2400 mg daily
Placebo
Placebo
Placebo matching active and experimental treatments
Interventions
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Dersalazine sodium
Dersalazine sodium 2400 mg daily
Mesalazine
Mesalazine 2400 mg daily
Placebo
Placebo matching active and experimental treatments
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Palau Pharma S.L.U.
INDUSTRY
Responsible Party
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Palau Pharma S.A.
Principal Investigators
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Julian Panés, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
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Investigational site 11
Kortrijk, , Belgium
Investigational site 1
Leuven, , Belgium
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
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
Investigational site 2
Badalona, , Spain
Investigational site 15
Barcelona, , Spain
Investigational site 3
Barcelona, , Spain
Investigational site 5
Barcelona, , Spain
Investigational site 21
Cadiz, , 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
Countries
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References
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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.
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.
Other Identifiers
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EudraCT 2008-004610-27
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR-IBD-1-08
Identifier Type: -
Identifier Source: org_study_id