Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA) - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00367315

Purpose

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

Condition	Intervention	Phase
Knee Osteoarthritis	Drug: Lumiracoxib	Phase III

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide Lumiracoxib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 13-Week, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Trial of 2 Different Dose Regimens of Lumiracoxib (100 mg od and 200 mg od Initial Dose for Two Weeks Followed by 100 mg od) in Patients With Primary Knee Osteoarthritis, Using Celecoxib (200 mg od) as a Comparator

Further study details as provided by Novartis:

Primary Outcome Measures:

Overall OA pain intensity in the target knee on a 0-100 mm Visual Analog Scale (VAS) at 13 weeks.
Patient's global assessment of disease activity on a 0-100 mm VAS at 13 weeks.
Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score at 13 weeks.

Secondary Outcome Measures:

• Overall OA pain intensity in the target knee using 0-100 mm VAS, at weeks 2, 4, 8.
Patient’s global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
Patient’s functional status using WOMAC© Likert 3.1 sub-scale scores and total score, at weeks 2, 8, 13.
Patient’s health status using the Short Form-36 (SF-36), at week 13.
Physician’s global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.

Estimated Enrollment:	1684
Study Start Date:	September 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

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).

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367315

Locations

Germany
Novartis
Nuernberg, Germany
Switzerland
Novartis
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

Novartis

More Information

Publications indexed to this study:

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.

Study ID Numbers:	CCOX189A2361
Study First Received:	August 18, 2006
Last Updated:	November 29, 2006
ClinicalTrials.gov Identifier:	NCT00367315
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Osteoarthritis, lumiracoxib, celecoxib, cyclooxygenase-2 inhibitors

Study placed in the following topic categories:

Prexige
Osteoarthritis, Knee
Celecoxib
Musculoskeletal Diseases

Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Cyclooxygenase 2 Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009