olpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE

• Conditions: Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis.; MedDRA version: 7.0Level: LLTClassification code 10045365

• Registration Number: EUCTR2004-001677-26-EE
• Lead Sponsor: Sanofi-Synthelabo Recherche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Male or female patients of at least 18 years old, with Ulcerative Colitis, of at least 6 months duration, that are 5-aminosalicylic acid or sulphasalazine resistant defined as a Disease Activity Index of the Mayo Score included in [6-10], despite a 4 weeks treatment of 5-ASA or sulphasalazine (at least 2 g/day).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Pregnant or breastfeeding women.
- Crohn´s disease.
- Positive stool cultures.
- Treatment with methotrexate or cyclosporine or corticosteroids over 20 mg/day of prednisolone.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy and clinical symptoms of two doses (1800 mg and 600 mg) of SR140333B, in patients with mild to moderate treatment [5-aminosalicylic acid (5-ASA) or sulphasalazine] resistant, Ulcerative Colitis, on top of this treatment compared to placebo.;Secondary Objective: Efficacy of SR140333B on pain reduction.<br>Endoscopical and histological effect of SR140333B.<br>Safety of SR140333B.;Primary end point(s): Clinical remission at 8 weeks defined as a Cinical Mayo score = 1 with no bleeding, with no initiation of rescue therapy for lack of efficacy (such as introduction or dose increase of corticoids, 5-ASA compounds or immuno-suppressant therapy).