Etoricoxib vs. Diclofenac in OA (0663-805)(COMPLETED)
A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Etoricoxib 60 mg and Diclofenac Sodium 150 mg in Patient With Osteoarthritis of the Knee or Hip
2 other identifiers
interventional
516
0 countries
N/A
Brief Summary
To compare the safety and tolerability of etoricoxib and diclofenac sodium in the treatment of osteoarthritis of the knee or hip during a six week period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2002
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 22, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2002
CompletedFirst Submitted
Initial submission to the registry
October 5, 2007
CompletedFirst Posted
Study publicly available on registry
October 10, 2007
CompletedAugust 15, 2024
February 1, 2022
9 months
October 5, 2007
August 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
This study will assess the effectiveness of the study drug vs. a comparator to treat successfully OA-related joint pain (judged by WOMAC pain subscale).
Secondary Outcomes (1)
The study drug will be safe and well tolerated during the course of the study.
Interventions
Eligibility Criteria
You may qualify if:
- Patient is at least 40 years old and diagnosed with osteoarthritis of the knee or hip
- Has a history of treatment with NSAIDs with positive therapeutic benefit
- Agree to limit alcohol intake to less than 7 drinks per week and avoid unusual strenuous activity
- Females who are able to have children must have negative urine pregnancy tests
You may not qualify if:
- Has rheumatoid arthritis, lupus, Paget's disease affecting the study joint, or Wilson's disease
- History of acute ligament or meniscus damage to the study joint (knee or hip) within the past 2 years or arthroscopic surgery on the affected study joint with the past 6 months
- Requires joint replacement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related Publications (1)
Zacher J, Feldman D, Gerli R, Scott D, Hou SM, Uebelhart D, Rodger IW, Ozturk ZE; etoricoxib OA study group. A comparison of the therapeutic efficacy and tolerability of etoricoxib and diclofenac in patients with osteoarthritis. Curr Med Res Opin. 2003;19(8):725-36. doi: 10.1185/030079903125002469.
PMID: 14687444BACKGROUND
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
October 5, 2007
First Posted
October 10, 2007
Study Start
March 22, 2002
Primary Completion
December 20, 2002
Study Completion
December 20, 2002
Last Updated
August 15, 2024
Record last verified: 2022-02