A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis

Phase 2

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: Dersalazine sodium; Drug: Placebo; Drug: Mesalazine

• Registration Number: NCT00808977
• Lead Sponsor: Palau Pharma S.L.U.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-15
• Study First Submitted QC: 2008-12-15
• Study First Posted: 2008-12-16
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-16
• Last Update Posted: 2010-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dersalazine	Dersalazine sodium	-
Placebo	Placebo	-
Mesalazine	Mesalazine	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal	7, 14, 21, 28, 56 days

Secondary Outcome Measures

Name	Time	Method
Mayo index	28 days

Trial Locations

Locations (22)

Investigational site 18; 🇸🇰 Košice, Slovakia

Investigational site 11; 🇧🇪 Kortrijk, Belgium

Investigational site 10; 🇭🇺 Eger, Hungary

Investigational site 20; 🇸🇰 Košice, Slovakia

Investigational site 17; 🇸🇰 Nové Zámky, Slovakia

Investigational site 8; 🇭🇺 Székesfehérvár, Hungary

Investigational site 19; 🇸🇰 Rožňava, Slovakia

Investigational site 7; 🇭🇺 Vác, Hungary

Investigational site 15; 🇪🇸 Barcelona, Spain

Investigational site 2; 🇪🇸 Badalona, Spain

Investigational site 16; 🇸🇰 Malacky, Slovakia

Investigational site 22; 🇪🇸 Madrid, Spain

Investigational site 6; 🇪🇸 Córdoba, Spain

Investigational site 14; 🇪🇸 Sabadell, Spain

Investigational site 13; 🇪🇸 Terrassa, Spain

Investigational site 4; 🇪🇸 Terrassa, Spain

Investigational site 1; 🇧🇪 Leuven, Belgium

Investigational site 12; 🇭🇺 Budapest, Hungary

Investigational site 9; 🇭🇺 Miskolc, Hungary

Investigational site 3; 🇪🇸 Barcelona, Spain

Investigational site 21; 🇪🇸 Cádiz, Spain

Investigational site 5; 🇪🇸 Barcelona, Spain