Back to resultsA Study Evaluating the Effect of Etoricoxib and Indomethacin in the Treatment of Acute Gout (0663-081)(COMPLETED)
Primary Purpose
Acute Gout
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
MK0663; etoricoxib / Duration of Treatment: 5 Days
Comparator: indomethacin 75 mg sustained release capsule / Duration of Treatment: 5 Days
Sponsored by
About this trial
This is an interventional treatment trial for Acute Gout focused on measuring Arcoxia
Eligibility Criteria
Inclusion Criteria: Males or females at least 18 years of age who have acute gout.
Sites / Locations
Outcomes
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00142558
Brief Title
A Study Evaluating the Effect of Etoricoxib and Indomethacin in the Treatment of Acute Gout (0663-081)(COMPLETED)
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2005 (Actual)
Primary Completion Date
May 1, 2005 (Actual)
Study Completion Date
May 1, 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
Brief Summary
A study to evaluate the effects of etoricoxib and indomethacin in the treatment of acute gout.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gout
Keywords
Arcoxia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0663; etoricoxib / Duration of Treatment: 5 Days
Intervention Type
Drug
Intervention Name(s)
Comparator: indomethacin 75 mg sustained release capsule / Duration of Treatment: 5 Days
Primary Outcome Measure Information:
Title
Patient assessment of pain (0- to 4- Likert scale)
Secondary Outcome Measure Information:
Title
Patient Global Assessment of Response to Therapy (0- to 4- point scale)
Title
Investigator Global Assessment of Response to Therapy (0- to 4- point scale)
Title
Tenderness of the study joint (0- to 3-point scale)
Title
Swelling of the study joint (0- to 3-point scale)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or females at least 18 years of age who have acute gout.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17588299
Citation
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. doi: 10.1185/030079907x210750.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
A Study Evaluating the Effect of Etoricoxib and Indomethacin in the Treatment of Acute Gout (0663-081)(COMPLETED)
We'll reach out to this number within 24 hrs