An Investigational Drug in Patients With Osteoarthritis (0663-073)
A 12-Week, Randomized, Placebo- and Active-Comparator-Controlled, Parallel-Group, Double-Blind Study to Assess the Safety and Efficacy of Etoricoxib 30 mg Versus Ibuprofen 2400 mg in Patients With Osteoarthritis (Study 2)
2 other identifiers
interventional
548
0 countries
N/A
Brief Summary
This study was conducted to assess the safety and tolerability of an investigational drug and to evaluate its effectiveness in the treatment of osteoarthritis of the hip or knee in both men and women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2003
Shorter than P25 for phase_3
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
April 9, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 13, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
November 13, 2003
CompletedFirst Submitted
Initial submission to the registry
September 23, 2004
CompletedFirst Posted
Study publicly available on registry
September 28, 2004
CompletedAugust 15, 2024
February 1, 2022
7 months
September 23, 2004
August 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
WOMAC VA 3.0 pain subscale, WOMAC VA 3.0 physical function subscale, and Patient Global Assessment of Disease Status Scale. Efficacy data collected at Weeks 2, 4, 8, and 12.
Secondary Outcomes (1)
Patient Global Assessment of Response to Therapy, Investigator Global Assessment of Disease Status, Womac VA 3.0: Stiffness, Overall Average Score and Overall Subscale Average. Clinical efficacy data collected at Weeks 2, 4, 8, and 12.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with osteoarthritis of the hip or knee who use current approved medication (nonsteroidal anti-inflammatory drugs (NSAIDs)) or tylenol to treat the symptoms of their osteoarthritis. Patients taking NSAIDs are required to discontinue using these drugs and their symptoms must become worse.
You may not qualify if:
- Patients with certain medical conditions may not be allowed to participate. These conditions will be reviewed with the study physician.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related Publications (1)
Puopolo A, Boice JA, Fidelholtz JL, Littlejohn TW, Miranda P, Berrocal A, Ko A, Cichanowitz N, Reicin AS. A randomized placebo-controlled trial comparing the efficacy of etoricoxib 30 mg and ibuprofen 2400 mg for the treatment of patients with osteoarthritis. Osteoarthritis Cartilage. 2007 Dec;15(12):1348-56. doi: 10.1016/j.joca.2007.05.022. Epub 2007 Jul 16.
PMID: 17631392BACKGROUND
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 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2004
First Posted
September 28, 2004
Study Start
April 9, 2003
Primary Completion
November 13, 2003
Study Completion
November 13, 2003
Last Updated
August 15, 2024
Record last verified: 2022-02