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OpenTrials
Completed

NCT Number: NCT00350155

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wiesbaden, Germany

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumiracoxib

Drug

Primary outcomes

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

Secondary outcomes

  1. Total number of small bowel mucosal breaks (with or without hemorrhage) detected by video capsule endoscopy

  2. Percentage of subjects with one or more small bowel lesion detected by video capsule endoscopy

  3. Total number of small bowel lesions detected by video capsule endoscopy

  4. Value of small bowel inflammation (as measured by calprotectin test)

  5. Value of lower GI permeability for lumiracoxib (as measured by differential urinary excretion of sugars)

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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.

Important dates

Study start
2006
First posted
Jul 10, 2006
Registry last updated
Dec 13, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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