Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)

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

1312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Brief Summary

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This 39-week, active controlled, study is designed to assess long-term efficacy, safety and tolerability of lumiracoxib 100mg od in patients with osteoarthritis (OA) of the knee who participated in the 13-week core CCOX189A2361 study.

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Detailed Description

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Conditions

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Osteoarthritis

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

* Any patient who completed the core study 2361 may enter the extension trial upon signing informed consent. A patient is defined as completing if he/she completed the core study 2361 up to and including Visit 6 (week 13) without a major protocol violation.

Exclusion Criteria

* Those patients for whom continued treatment in the extension study is not considered appropriate by the treating physician
* Those patients who were non-compliant or who demonstrated a major protocol violation in the core study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No