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

December 12, 2007 updated by: Novartis

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Study Registration Dates

First Submitted

July 5, 2006

First Submitted That Met QC Criteria

July 5, 2006

First Posted (ESTIMATE)

July 10, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

December 13, 2007

Last Update Submitted That Met QC Criteria

December 12, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCOX189A2425

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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