Video Capsule Endoscopy to Investigate the Safety and Tolerability of Lumiracoxib in the Small Bowel
Phase 4
Completed
- Conditions
- Healthy Volunteers
- Registration Number
- NCT00350155
- Lead Sponsor
- Novartis
- Brief Summary
This study is designed to investigate the potential differences in GI safety and tolerability in the small bowel between lumiracoxib, conventional non-selective NSAID (naproxen) with a proton pump inhibitor (omeprazole), or placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- Healthy male or female subjects
Exclusion Criteria
- Evidence of cardiovascular, hepatic, gastrointestinal or renal disorders
- Hereditary problems of galactose intolerance, a severe lactase deficiency or glucose-galactose malabsorption syndrome
- Smokers
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage of subjects with one or more small bowel mucosal breaks (with or without hemorrhage) detected by video capsule endoscopy
- Secondary Outcome Measures
Name Time Method Total number of small bowel mucosal breaks (with or without hemorrhage) detected by video capsule endoscopy Percentage of subjects with one or more small bowel lesion detected by video capsule endoscopy Total number of small bowel lesions detected by video capsule endoscopy Value of small bowel inflammation (as measured by calprotectin test) Value of lower GI permeability for lumiracoxib (as measured by differential urinary excretion of sugars)