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 4

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

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 ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by Merck:

Arcoxia

Additional relevant MeSH terms:

Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Indomethacin
Etoricoxib
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
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on May 21, 2012