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

Novartis150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Healthy Volunteers

Interventions

LumiracoxibDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Unnamed facility

Wiesbaden, Germany

Unnamed facility

Nottingham, United Kingdom

Outcomes

Primary Outcomes

Percentage of subjects with one or more small bowel mucosal breaks (with or without hemorrhage) detected by video capsule endoscopy

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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