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NCT00350155 Clinical Trial

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

Healthy Volunteers Clinical Trial

Official title:
A 16-Day, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Trial Comparing Lumiracoxib 100mg o.d. With Naproxen 500 mg b.i.d. Plus Omeprazole 20mg o.d. and Placebo in Healthy Volunteers to Investigate on the Safety and Tolerability of Lumiracoxib in the Small Bowel.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00350155
Other study ID # CCOX189A2425
Secondary ID
Status Completed
Phase Phase 4
First received July 5, 2006
Last updated December 12, 2007
Start date May 2006

Study information
Verified date December 2007
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lumiracoxib

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of subjects with one or more small bowel mucosal breaks (with or without hemorrhage) detected by video capsule endoscopy
Secondary Total number of small bowel mucosal breaks (with or without hemorrhage) detected by video capsule endoscopy
Secondary Percentage of subjects with one or more small bowel lesion detected by video capsule endoscopy
Secondary Total number of small bowel lesions detected by video capsule endoscopy
Secondary Value of small bowel inflammation (as measured by calprotectin test)
Secondary Value of lower GI permeability for lumiracoxib (as measured by differential urinary excretion of sugars)
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