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:	NCT00475800

Purpose

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.

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, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A 39-Week, Open-Label Extension to CCOX189A2360, 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 assess long-term safety and tolerability in patients who were exposed in the core study for 13 weeks to either lumiracoxib, celecoxib or placebo and who will be exposed to lumiracoxib 100 mg od for an additional 39 weeks.

Secondary Outcome Measures:

Overall OA pain intensity (Target knee) 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.

Enrollment:	833
Study Start Date:	January 2004

Eligibility

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

Criteria

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

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475800

Locations

United States, Arizona

Tucson, Arizona, United States, 85723
United States, Minnesota

Brooklyn Park, Minnesota, United States, 55430
United States, New Mexico

Albuquerque, New Mexico, United States, 87109
United States, South Dakota

Sioux Falls, South Dakota, United States, 57105
United States, Texas

San Antonio, Texas, United States, 78232
Canada, Ontario
Novartis Investigative Site
Brampton, Ontario, Canada

Sponsors and Collaborators

Novartis

More Information

Study ID Numbers:	CCOX189A2360E1
Study First Received:	May 18, 2007
Last Updated:	May 18, 2007
ClinicalTrials.gov Identifier:	NCT00475800
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

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