52 Week, International, Multi-Center, Randomized, Double-Blind, Double-Dummy, Parallel-Group Clinical Trial to Compare Retention on Treatment, Safety, Tolerability & Efficacy of Lumiracoxib 100 mg od, Lumiracoxib 100 mg Bid & Celecoxib 200 mg od in Pts With Primary OA of Hip, Knee, Hand or Spine - Full Text View

52 Week, International, Multi-Center, Randomized, Double-Blind, Double-Dummy, Parallel-Group Clinical Trial to Compare Retention on Treatment, Safety, Tolerability & Efficacy of Lumiracoxib 100 mg od, Lumiracoxib 100 mg Bid & Celecoxib 200 mg od in Pts With Primary OA of Hip, Knee, Hand or Spine

This study has been completed.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00145301

Purpose

This trial will compare the retention on treatment (based on the rate of patients staying on treatment for 1 year) of patients suffering from primary osteoarthritis using two different doses of lumiracoxib (100 mg od or 100 mg bid) or using celecoxib (200 mg od)

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 52-Week, International, Multi-Center, Randomized, Double-Blind, Double-Dummy, Parallel-Group Clinical Trial to Compare Retention on Treatment, Safety, Tolerability and Efficacy of Lumiracoxib 100 mg od, Lumiracoxib 100 mg Bid and Celecoxib 200 mg od in Patients With Primary Osteoarthritis of Hip, Knee, Hand or Spine

Further study details as provided by Novartis:

Primary Outcome Measures:

To show that either regimen of lumiracoxib (100mg od or 100mg bid) is not inferior to celecoxib 200mg od with respect to retention rate at 1 year in pts suffering from primary OA in hip, knee, hand or spine.

Secondary Outcome Measures:

Safety & tolerability of pts using lumiracoxib vs pts using celecoxib
Efficacy of lumiracoxib vs celecoxib with respect to Patient’s assessment of OA pain, Patient’s global assessment of disease activity, and Physician’s global assessment of disease activity
To compare reasons for discontinuation from treatment with lumiracoxib vs treatment with celecoxib
To validate the psychometric properties of the Short Arthritis assessment Scale (SAS) by analyzing pt reported outcomes collected in this study

Estimated Enrollment:	3036
Study Start Date:	September 2004

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Primary osteoarthritis in the hip, knee, hand, or spine
Requiring NSAID therapy

Exclusion Criteria:

Secondary OA with history and/ or any evidence of the following diseases: rheumatoid arthritis, uncontrolled gout, inflammatory joint disease, ochronosis, acromegaly, hemochromatosis, Wilson’s disease, primary osteochondromatosis, heritable disorders (e.g. hypermobility), collagen gene mutations, primary fibromyalgia (secondary fibromyalgia is allowed if in the opinion of the investigator it will not interfere with the patient’s OA pain assessment), and systemic lupus erythematosus
History and/ or any evidence of the following diseases in the target joint: septic arthritis, gout, recurrent episodes of pseudogout, Paget’s disease of the bone, and articular fracture. If the patient has history of these conditions, then patient should only be excluded if the target joint is affected.
History of severe adverse reactions of any kind under lumiracoxib or celecoxib treatment.

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145301

Locations


Germany
	Novartis
	Nuernberg, Germany

Sponsors and Collaborators

Novartis

More Information

Publications indexed to this study:

Fleischmann R, Tannenbaum H, Patel NP, Notter M, Sallstig P, Reginster JY. Long-term retention on treatment with lumiracoxib 100 mg once or twice daily compared with celecoxib 200 mg once daily: a randomised controlled trial in patients with osteoarthritis. BMC Musculoskelet Disord. 2008 Mar 7;9:32.

Study ID Numbers:	CCOX189A2369
First Received:	September 1, 2005
Last Updated:	November 29, 2006
ClinicalTrials.gov Identifier:	NCT00145301
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Osteoarthritis, lumiracoxib, retention on treatment, efficacy, safety

Study placed in the following topic categories:

Prexige

Celecoxib

Musculoskeletal Diseases

Osteoarthritis

Joint Diseases

Arthritis

Rheumatic Diseases

Osteoarthritis, Hip

Urinary Retention

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 October 31, 2008