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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00350155

Enrollment

150

Registered

2006-07-10

Start date

2006-05-31

Completion date

Unknown

Last updated

2007-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Video capsule endoscopy, healthy volunteers, naproxen, omeprazole, lumiracoxib, small bowel

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.

Interventions

DRUGLumiracoxib

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

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

Secondary

Measure	Time frame
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)	—

Countries

Germany, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026