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

NCT00808977 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2010-11-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dersalazine sodium

Dersalazine sodium 2400 mg daily

DRUG

Mesalazine

Mesalazine 2400 mg daily

DRUG

Placebo

Placebo matching active and experimental treatments

Sponsors & Collaborators

  • Palau Pharma S.L.U.

    lead INDUSTRY

Principal Investigators

  • Julian Panés, MD · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Belgium
  • Hungary
  • Slovakia
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00808977 on ClinicalTrials.gov