A Study Evaluating the Effect of Etoricoxib and Indomethacin in the Treatment of Acute Gout - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00142558

Purpose

A study to evaluate the effects of etoricoxib and indomethacin in the treatment of acute gout.

Condition	Intervention	Phase
Acute Gout	Drug: MK0663; etoricoxib / Duration of Treatment: 5 Days Drug: Comparator: indomethacin 75 mg sustained release capsule / Duration of Treatment: 5 Days	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Active-Comparator-Controlled 5-Day Trial of the Effect of Etoricoxib 120 mg Versus Indomethacin 150 mg in the Treatment of Acute Gout

Resource links provided by NLM:

MedlinePlus related topics: Gout

Drug Information available for: Indomethacin Etoricoxib

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Patient assessment of pain (0- to 4- Likert scale)

Secondary Outcome Measures:

Patient Global Assessment of Response to Therapy (0- to 4- point scale)
Investigator Global Assessment of Response to Therapy (0- to 4- point scale)
Tenderness of the study joint (0- to 3-point scale)
Swelling of the study joint (0- to 3-point scale)

Enrollment:	180
Study Start Date:	January 2005
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria:

Males or females at least 18 years of age who have acute gout.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142558

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided by Merck

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Navarra S, Rubin BR, Yu Q, Smugar SS, Tershakovec AM. Association of baseline disease and patient characteristics with response to etoricoxib and indomethacin for acute gout. Curr Med Res Opin. 2007 Jul;23(7):1685-91.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_062, MK0663-081
Study First Received:	August 31, 2005
Last Updated:	January 14, 2010
ClinicalTrials.gov Identifier:	NCT00142558 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Merck:

Arcoxia

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Reproductive Control Agents
Gout Suppressants
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Musculoskeletal Diseases
Tocolytic Agents
Sensory System Agents
Arthritis
Therapeutic Uses
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics

Metabolic Diseases
Joint Diseases
Etoricoxib
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Cardiovascular Agents
Rheumatic Diseases
Gout
Pharmacologic Actions
Genetic Diseases, Inborn
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010