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-CZ
- Lead Sponsor
- sanofi-aventis recherche & developpement
- Brief Summary
Not available
- Detailed Description
Not available
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.
- Chrön disease.
- Positive stool cultures.
- Treatment with methotrexate or cyclosporine or corticosteroïds 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
- Secondary Outcome Measures
Name Time Method