Efficacy and Safety Study of Lumiracoxib in Patients With Primary Hip Osteoarthritis

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

PHASE3

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Brief Summary

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The purpose of this study is to evaluate the efficacy, tolerability, and safety of the investigational drug, lumiracoxib as compared to celecoxib and placebo in subjects with hip osteoarthritis. Both lumiracoxib and celecoxib belong to the same class of drug (COX-2 selective nonsteroidal anti-inflammatory drugs \[NSAIDs\]).

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Detailed Description

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Conditions

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Osteoarthritis, Hip

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 (drug)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of primary hip osteoarthritis
* Qualifying pain intensity in the hip joint
* Requiring NSAID therapy

Exclusion Criteria

* Rheumatoid arthritis or other inflammatory joint disease
* Disease or disorder that may interfere with pain assessment of the hip
* Open knee/hip surgery within the last year
* Past history of heart attack, stroke or angina (chest pain)
* Liver disorder
* History of severe adverse reactions of any kind under lumiracoxib or celecoxib treatment

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No