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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00808977
Other study ID # CR-IBD-1-08
Secondary ID EudraCT 2008-004
Status Completed
Phase Phase 2
First received December 15, 2008
Last updated November 16, 2010
Start date December 2008
Est. completion date June 2010

Study information

Verified date November 2010
Source Palau Pharma S.A.
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health ProductsSpain: Spanish Agency of MedicinesHungary: National Institute of PharmacySlovakia: State Institute for Drug Control
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Dersalazine sodium
Dersalazine sodium 2400 mg daily
Mesalazine
Mesalazine 2400 mg daily
Placebo
Placebo matching active and experimental treatments

Locations

Country Name City State
Belgium Investigational site 11 Kortrijk
Belgium Investigational site 1 Leuven
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
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 Rožnava
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

Sponsors (1)

Lead Sponsor Collaborator
Palau Pharma S.A.

Countries where clinical trial is conducted

Belgium,  Hungary,  Slovakia,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal 7, 14, 21, 28, 56 days Yes
Secondary Mayo index 28 days No
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