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

NCT ID: NCT00367315

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

1684 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Brief Summary

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This study will evaluate the efficacy and safety of using lumiracoxib in the treatment of patients with knee osteoarthritis (OA)

Detailed Description

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Conditions

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Knee 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

* Primary osteoarthritis of knee (confirmed by American College of Rheumatology \[ACR\] criteria).
* Requirement of regular non-steroidal anti-inflammatory drug (NSAID) therapy.

Exclusion Criteria

* Evidence of active peptic ulceration within 12 months prior to the screening visit or history of active gastrointestinal bleeding within the previous 5 years.
* Known hypersensitivity to analgesics, antipyretics, or NSAIDS (including celecoxib).
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

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_CHAIR

Novartis

Locations

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Novartis

Nuremberg, , Germany

Site Status

Novartis

Basel, , Switzerland

Site Status

Countries

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Germany Switzerland

References

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Dougados M, Moore A, Yu S, Gitton X. Evaluation of the patient acceptable symptom state in a pooled analysis of two multicentre, randomised, double-blind, placebo-controlled studies evaluating lumiracoxib and celecoxib in patients with osteoarthritis. Arthritis Res Ther. 2007;9(1):R11. doi: 10.1186/ar2118.

Reference Type DERIVED
PMID: 17266764 (View on PubMed)

Other Identifiers

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CCOX189A2361

Identifier Type: -

Identifier Source: org_study_id

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