Clinical trial NCT00808977: A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: Palau Pharma S.L.U.
Sponsor class: INDUSTRY
First posted: 2008-12-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal
timeFrame: 7, 14, 21, 28, 56 days
Secondary outcomes:
measure: Mayo index
timeFrame: 28 days
Other outcomes:
Locations:
city: Kortrijk
country: Belgium
facility: Investigational site 11
city: Leuven
country: Belgium
facility: Investigational site 1
city: Budapest
country: Hungary
facility: Investigational site 12
city: Eger
country: Hungary
facility: Investigational site 10
city: Miskolc
country: Hungary
facility: Investigational site 9
city: Székesfehérvár
country: Hungary
facility: Investigational site 8
city: Vác
country: Hungary
facility: Investigational site 7
city: Košice
country: Slovakia
facility: Investigational site 18
city: Košice
country: Slovakia
facility: Investigational site 20
city: Malacky
country: Slovakia
facility: Investigational site 16
city: Nové Zámky
country: Slovakia
facility: Investigational site 17
city: Rožňava
country: Slovakia
facility: Investigational site 19
city: Badalona
country: Spain
facility: Investigational site 2
city: Barcelona
country: Spain
facility: Investigational site 15
city: Barcelona
country: Spain
facility: Investigational site 3
city: Barcelona
country: Spain
facility: Investigational site 5
city: Cádiz
country: Spain
facility: Investigational site 21
city: Córdoba
country: Spain
facility: Investigational site 6
city: Madrid
country: Spain
facility: Investigational site 22
city: Sabadell
country: Spain
facility: Investigational site 14
city: Terrassa
country: Spain
facility: Investigational site 13
city: Terrassa
country: Spain
facility: Investigational site 4
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Julian Panés, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.