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Nolpitantium Besylate In Patients With Ulcerative Colitis a Double-Blind, Placebo Controlled Efficacy and Safety Study

NCT00232258 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 307

Last updated 2008-12-10

No results posted yet for this study

Summary

To evaluate the safety and efficacy on clinical symptoms, mucosal histology and endoscopic mucosal appearance of two doses of SR140333B against placebo in patients with mild to moderate ulcerative colitis resistant to treatment with 5-ASA.

Conditions

Interventions

DRUG

Nolpitantium besylate

Sponsors & Collaborators

Principal Investigators

  • Gert Van Assche, MD · Universitaire Ziekenhizen Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2006-09-30
Completion
2006-09-30

Countries

  • Argentina
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Czechia
  • Estonia
  • Hungary
  • Italy
  • Russia
  • Singapore
  • South Africa
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00232258 on ClinicalTrials.gov