A 26-Week, Randomized, Placebo- and Active-Comparator-Controlled, Parallel-Group, Double-Blind, 2-Part Study to Assess the Safety and Efficacy of Etoricoxib 30 mg Versus Celecoxib 200 mg in Patients With Osteoarthritis (Study 1)
Sponsor study identifier
Secondary identifiers
interventional
500
0 countries
N/A
Study Start
March 1, 2004
Actual (reported)Primary Completion
February 1, 2005
Actual (reported)Study Completion
February 1, 2005
Actual (reported)The purpose of this study is to compare the safety and effectiveness of an investigational drug and an approved drug in the treatment of osteoarthritis of the knee and hip.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2005
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2004
Actual (reported)September 23, 2004
Actual (reported)September 28, 2004
Actual (reported)February 1, 2005
Actual (reported)February 1, 2005
Actual (reported)Osteoarthritis of the knee & hip as assessed by WOMAC VA 3.0 pain and physical function subscales, Patient/Investigator assessments of disease and response to therapy over 12 weeks of treatment.
Maintenance of clinical efficacy as assessed by WOMAC subscales and Patient assessments over a 26-wks of treatment. Safety / tolerability over a 12-wk and 6-mo treatment period.
Bingham CO 3rd, Sebba AI, Rubin BR, Ruoff GE, Kremer J, Bird S, Smugar SS, Fitzgerald BJ, O'Brien K, Tershakovec AM. Efficacy and safety of etoricoxib 30 mg and celecoxib 200 mg in the treatment of osteoarthritis in two identically designed, randomized, placebo-controlled, non-inferiority studies. Rheumatology (Oxford). 2007 Mar;46(3):496-507. doi: 10.1093/rheumatology/kel296. Epub 2006 Aug 27.
Bingham CO 3rd, Bird SR, Smugar SS, Xu X, Tershakovec AM. Responder analysis and correlation of outcome measures: pooled results from two identical studies comparing etoricoxib, celecoxib, and placebo in osteoarthritis. Osteoarthritis Cartilage. 2008 Nov;16(11):1289-93. doi: 10.1016/j.joca.2008.04.009. Epub 2008 Jun 2.
Medical Monitor
Merck Sharp & Dohme LLC
500 participants (actual enrollment reported by the registry).
First Submitted
September 23, 2004
First Posted
September 28, 2004
Study Start
March 1, 2004
Actual (reported)Contact the study team to confirm eligibility.
Bingham CO 3rd, Smugar SS, Wang H, Tershakovec AM. Early response to COX-2 inhibitors as a predictor of overall response in osteoarthritis: pooled results from two identical trials comparing etoricoxib, celecoxib and placebo. Rheumatology (Oxford). 2009 Sep;48(9):1122-7. doi: 10.1093/rheumatology/kep184. Epub 2009 Jul 9.
Primary Completion
February 1, 2005
Actual (reported)Study Completion
February 1, 2005
Actual (reported)Last Updated
August 15, 2024
Record last verified: 2022-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: