Etoricoxib in the Treatment of Osteoarthritis (MK-0663-007)
A Placebo-Controlled, Parallel-Group, Double-Blind Study to Assess Safety and to Define the Clinically Effective Dose Range of MK0663 in Patients With Osteoarthritis of the Knee, Followed by a Double-Blind, Active-Comparator-Controlled Extension.
2 other identifiers
interventional
1,167
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of etoricoxib in the treatment of osteoarthritis of the knee.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 1998
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 1998
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 18, 2005
CompletedFirst Posted
Study publicly available on registry
October 20, 2005
CompletedFebruary 18, 2022
February 1, 2022
8 months
October 18, 2005
February 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
WOMAC Pain Subscale, Investigator Global Assessment of Disease Status, and Patient Global Assessment of Response to Therapy (not a primary endpoint in extension periods)
Secondary Outcomes (1)
Physical Function Subscale (WOMAC), Stiffness Subscale (WOMAC), Patient Global Assessment of Disease Status, Investigator Global Assessment of Response to Therapy , Proportion of Patients Discontinued Due to Lack of Efficacy
Interventions
Eligibility Criteria
You may qualify if:
- At least 40 years of age with a clinical diagnosis of Osteoarthritis (OA)of the knee for 6 months prior to study entry (ARA class I, II, or III).
- Positive therapeutic effect from prior NSAID therapy.
- Worsening of symptoms upon withdrawal of prior treatment.
- With the exception of OA, in otherwise good health
You may not qualify if:
- Weight no more than 280 pounds (male or female).
- Recent, sustained use of gastroprotective agents.
- History of arthroscopy of the affected knee within 6 months prior to study entry.
- History of acute ligamentous or meniscal injury of the study joint within the previous 2 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related Publications (2)
Gottesdiener K, Schnitzer T, Fisher C, Bockow B, Markenson J, Ko A, DeTora L, Curtis S, Geissler L, Gertz BJ; Protocol 007 Study Group. Results of a randomized, dose-ranging trial of etoricoxib in patients with osteoarthritis. Rheumatology (Oxford). 2002 Sep;41(9):1052-61. doi: 10.1093/rheumatology/41.9.1052.
PMID: 12209041BACKGROUNDCurtis SP, Bockow B, Fisher C, Olaleye J, Compton A, Ko AT, Reicin AS. Etoricoxib in the treatment of osteoarthritis over 52-weeks: a double-blind, active-comparator controlled trial [NCT00242489]. BMC Musculoskelet Disord. 2005 Dec 1;6:58. doi: 10.1186/1471-2474-6-58.
PMID: 16321158RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2005
First Posted
October 20, 2005
Study Start
June 1, 1998
Primary Completion
February 1, 1999
Study Completion
July 1, 2002
Last Updated
February 18, 2022
Record last verified: 2022-02