Osteoarthritis
Conditions
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.
Interventions
DRUGMK0663, etoricoxib / Duration of Treatment: 6 Weeks
DRUGComparator: diclofenac sodium / Duration of Treatment: 6 Weeks
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| The study drug will be safe and well tolerated during the course of the study. | — |
Outcome results
None listed