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A Study Evaluating the Effect of Etoricoxib and Indomethacin in the Treatment of Acute Gout

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00142558
First received: August 31, 2005
Last updated: January 14, 2010
Last verified: January 2010
History of Changes
  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
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):

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: 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 June 17, 2013