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:	NCT00476034

Purpose

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.

Condition	Intervention	Phase
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 39-Week, Double-Blind, Active-Controlled Extension to CCOX189A2361, 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:

To compare lumiracoxib 100mg od to celecoxib 200mg od in treating osteoarthritis (OS) of the target knee with respect to:
Overall OA pain intensity in the target knee on a 0-100 mm Visual Analog Scale (VAS) at 26 weeks.
Patient’s global assessment of disease activity on a 0-100mm VAS at 26 weeks.
Patient’s functional status using the WOMAC total score at 26 weeks

Secondary Outcome Measures:

To assess the safety and tolerability profile of lumiracoxib as compared to celecoxib
To assess the efficacy of lumiracoxib as compared to celecoxib with respect to:
Overall OA pain intensity on a 0-100 mm VAS by visit
Patient’s global assessment of disease activity by visit
Physician’s global assessment of disease activity by visit
Patient’s functional status using the WOMAC 3.1 LK sub-scale scores and total score by visit
Usage of rescue medication
Response to treatment according to OARSI criteria by visit

Enrollment:	1312
Study Start Date:	December 2003

Eligibility

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

Criteria

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.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476034

Locations

Australia
Novartis Investigative Site
Malvern, Australia
Austria
Novartis Investigative Site
Vienna, Austria
Czech Republic
Novartis Investigative Site
Prague, Czech Republic
Finland
Novartis Investigative Site
Turku, Finland
Germany
Novartis Investigative Site
Dresden, Germany
Hungary
Novartis Investigative Site
Budapest, Hungary
Israel
Novartis Investigative Site
Haifa, Israel
Netherlands
Novartis Investigative Site
Lisse, Netherlands
New Zealand
Novartis Investigative Site
Rotorua, New Zealand
Poland
Novartis Investigative Site
Poznan, Poland
Slovakia
Novartis Investigative Site
Bratislava, Slovakia
South Africa
Novartis Investigative Site
Johannesburg, South Africa
Spain
Novartis Investigative Site
Sevilla, Spain
Sweden
Novartis Investigative Site
Uppsala, Sweden
Turkey
Novartis Investigative Site
Izmir, Turkey

Sponsors and Collaborators

Novartis

More Information

Study ID Numbers:	CCOX189A2361E1
Study First Received:	May 18, 2007
Last Updated:	May 18, 2007
ClinicalTrials.gov Identifier:	NCT00476034
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Austria: Federal Agency for Safety in Health Care; Australia: Department of Health and Ageing Therapeutic Goods Administration; Czech Republic: State Institute for Drug Control; Finland: National Agency for Medicines; Hungary: National Institute of Pharmacy; Israel: Ministry of Health; Netherlands: Medicines Evaluation Board (MEB); New Zealand: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Slovakia: State Institute for Drug Control; South Africa: Department of Health; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Turkey: Ministry of Health

Keywords provided by Novartis:

Osteoarthritis
lumiracoxib
celecoxib
Cox-2
knee

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