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

NCT ID: NCT00475800

Last Updated: 2012-05-21

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

833 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Brief Summary

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This 39-week, open label 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 CCOX189A2360 study.

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Lumiracoxib

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have completed the core CCOX189A2360 study
* Males and females over the 18 years old

Exclusion Criteria

* Treatment in the extension study is not considered appropriate by the treating physician
* Non-compliance or major protocol violation of the core study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tucson, Arizona, United States

Site Status

Brooklyn Park, Minnesota, United States

Site Status

Albuquerque, New Mexico, United States

Site Status

Sioux Falls, South Dakota, United States

Site Status

San Antonio, Texas, United States

Site Status

Novartis Investigative Site

Brampton, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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CCOX189A2360E1

Identifier Type: -

Identifier Source: org_study_id

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