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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00808977

Enrollment

Registered

2008-12-16

Start date

2008-12-31

Completion date

2010-06-30

Last updated

2010-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

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.

Interventions

DRUGDersalazine sodium

Dersalazine sodium 2400 mg daily

DRUGMesalazine

Mesalazine 2400 mg daily

DRUGPlacebo

Placebo matching active and experimental treatments

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Mayo index	28 days

Countries

Belgium, Hungary, Slovakia, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026