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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Lumiracoxib

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Novartis Pharma AG

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

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Wiesbaden, , Germany

Site Status

Nottingham, , United Kingdom

Site Status

Countries

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Germany United Kingdom

Other Identifiers

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CCOX189A2425

Identifier Type: -

Identifier Source: org_study_id