Efficacy and Safety of Lumiracoxib 400 mg Once Daily in Acute Flares of Gout - Full Text View

Purpose

This study is designed to develop our understanding of the efficacy and safety of using lumiracoxib in the treatment of patients with acute gout. This is a multi-center, double-blind, randomized, parallel group study comparing a single daily dose of 400 mg lumiracoxib with the established dose of indomethacin 50 mg taken three times a day in terms of efficacy

Condition	Intervention	Phase
Acute Gouty Arthritis	Drug: Lumiracoxib	Phase IV

MedlinePlus related topics:

Gout

Drug Information available for:

Lumiracoxib Indomethacin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A 1-Week, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Parallel Trial Comparing Lumiracoxib (400 mg Once Daily) in Patients With Acute Flares of Gout, Using Indomethacin (50 mg Three Times a Day)

Further study details as provided by Novartis:

Primary Outcome Measures:

Pain intensity in the study joint over days 2 to 5 approximately 4h after the first daily dose

Secondary Outcome Measures:

Safety and tolerability profile
Pain intensity in the study joint over the entire treatment period
Patient’s and Physician’s global assessment of response to therapy
Physician’s assessment of tenderness and swelling of study joint
C-reactive protein level
Proportion of patients who discontinued treatment because of a lack of efficacy
Usage of rescue medication
SF-36 and EQ-5D
Physician’s assessment of erythema of study joint

Estimated Enrollment:	234
Study Start Date:	June 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ambulatory cooperative male or female patients of at least 18 years of age
With an acute attack of gout in 4 joints or less, diagnosed clinically according to the ACR 1977 classification criteria and with an onset within the last 48 hours prior to evaluation. Where more than one joint is involved, the most affected joint should be identified, as the study joint, at baseline and followed throughout the study
Who present at Baseline with an acute pain intensity of at least moderate.

Exclusion Criteria:

With an acute attack of gout before the last 48 hours prior to evaluation
With polyarticular gout involving > 4 joints
With rheumatoid arthritis, infectious arthritis, pseudo-gout or other acute inflammatory arthritides.

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170781

Locations


Germany
	Novartis
	Nuernberg, Germany

Switzerland, CH
	For Site Information, contact Novartis Pharma AG
	Basel, CH, Switzerland, 4002

Sponsors and Collaborators

Novartis

Investigators


Study Chair:	Novartis Pharma AG	Sponsor GmbH

More Information

Study ID Numbers:	CCOX189A2426
First Received:	September 9, 2005
Last Updated:	November 29, 2006
ClinicalTrials.gov Identifier:	NCT00170781
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Pain, acute gout, arthritis, cyclooxygenase-2 inhibitors, lumiracoxib, indomethacin

Study placed in the following topic categories:

Prexige

Metabolic Diseases

Joint Diseases

Pain

Rheumatic Diseases

Gout

Purine-Pyrimidine Metabolism, Inborn Errors

Arthritis, Gouty

Metabolism, Inborn Errors

Musculoskeletal Diseases

Genetic Diseases, Inborn

Arthritis

Indomethacin

Metabolic disorder

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 November 06, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00170781