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

Tracking Information

First Received Date ^ICMJE

August 31, 2005

Last Updated Date

January 14, 2010

Start Date ^ICMJE

January 2005

Primary Completion Date

May 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00142558 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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)

Original Secondary Outcome Measures ^ICMJE

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)

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Acute Gout

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

180

Completion Date

Primary Completion Date

May 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00142558

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2005_062, MK0663-081

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP