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

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

Date First Received: August 31, 2005

Last Updated: September 30, 2008

Verified by: Merck, September 2008

Clinical Trial Phase: Phase 4 | Start Date: January 2005

Overall Status: Completed

Estimated Enrollment: 180

Brief Summary

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”

Condition Keyword(s):

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2005

Intervention(s) in this Clinical Trial

  • Drug: MK0663; etoricoxib / Duration of Treatment: 5 Days
  • Drug: Comparator: indomethacin 75 mg sustained release capsule / Duration of Treatment: 5 Days

Outcome Measures for this Clinical Trial

Primary Measures

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

Secondary 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)

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00142558

Study ID Number: 2005_062

ClinicalTrials.gov Identifier: NCT00142558

Health Authority: China: State Food and Drug Administration

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