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A Study Evaluating the Effect of Etoricoxib and Indomethacin in the Treatment of Acute Gout (0663-081)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00142558
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Actual Study Start Date : January 1, 2005
Actual Primary Completion Date : May 1, 2005
Actual Study Completion Date : May 1, 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gout
U.S. FDA Resources




Primary Outcome Measures :
  1. Patient assessment of pain (0- to 4- Likert scale)

Secondary Outcome Measures :
  1. Patient Global Assessment of Response to Therapy (0- to 4- point scale)
  2. Investigator Global Assessment of Response to Therapy (0- to 4- point scale)
  3. Tenderness of the study joint (0- to 3-point scale)
  4. Swelling of the study joint (0- to 3-point scale)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00142558


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00142558     History of Changes
Other Study ID Numbers: 0663-081
MK0663-081
2005_062
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017

Keywords provided by Merck Sharp & Dohme Corp.:
Arcoxia

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Indomethacin
Etoricoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors