- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00092768
A Study of MK0663 and an Approved Drug in the Treatment of Osteoarthritis (0663-076)(COMPLETED)
February 4, 2022 updated by: Organon and Co
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The duration of treatment is 26 weeks.
Study Type
Interventional
Enrollment (Actual)
500
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Osteoarthritis of the knee or hip which requires treatment with a medication to obtain pain relief
Exclusion Criteria:
- Any known allergy to the study drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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.
|
Secondary Outcome Measures
Outcome Measure |
---|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2004
Primary Completion (Actual)
February 1, 2005
Study Completion (Actual)
February 1, 2005
Study Registration Dates
First Submitted
September 23, 2004
First Submitted That Met QC Criteria
September 27, 2004
First Posted (Estimate)
September 28, 2004
Study Record Updates
Last Update Posted (Actual)
February 16, 2022
Last Update Submitted That Met QC Criteria
February 4, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Celecoxib
- Etoricoxib
Other Study ID Numbers
- 0663-076
- 2004_057
Plan for Individual participant data (IPD)
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoarthritis
-
Sanford HealthActive, not recruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder Osteoarthritis | Ankle Osteoarthritis | Wrist OsteoarthritisUnited States
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
University of California, San FranciscoStanford University; Robert Wood Johnson FoundationCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
University of VermontCompletedOsteoarthritis of Knee | Osteoarthritis Of HipUnited States
-
University of EdinburghHospital for Special Surgery, New YorkRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited Kingdom
-
Mayo ClinicCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
Sword Health, SAHospital da PreladaCompletedEfficacy of a Digital Biofeedback System for Home-based Rehabilitation After Total Joint ReplacementKnee Osteoarthritis | Hip OsteoarthritisPortugal
-
The Hawkins FoundationCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
Massachusetts General HospitalNewton-Wellesley HospitalCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
Clinical Trials on MK0663, etoricoxib
-
Organon and CoCompletedAcute Pain Following a Total Abdominal Hysterectomy
-
Organon and CoCompleted
-
University of Erlangen-Nürnberg Medical SchoolMerck Sharp & Dohme LLC; Rush University Medical Center; HELIOS Kliniken GmbHTerminatedPain | Postoperative Pain | Osteoarthritis, HipGermany
-
Organon and CoCompleted
-
Organon and CoCompleted
-
Organon and CoCompleted
-
Organon and CoCompleted
-
Organon and CoWithdrawn
-
Organon and CoCompleted