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

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Gout

Drug Information available for: Indomethacin Lumiracoxib

U.S. FDA Resources

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
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

No publications provided

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

Keywords provided by Novartis:

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

Additional relevant MeSH terms:

Arthritis
Arthritis, Gouty
Joint Diseases
Musculoskeletal Diseases
Gout
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Indomethacin
Lumiracoxib
Diclofenac
Cyclooxygenase 2 Inhibitors
Gout Suppressants

Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012