Video Capsule Endoscopy to Investigate the Safety and Tolerability of Lumiracoxib in the Small Bowel

Novartis

Status and phase: Completed; Phase 4

Conditions: Healthy Volunteers

Treatments: Drug: Lumiracoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00350155

CCOX189A2425

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind