DOUBLE-BLIND, ONE YEAR PARALLEL GROUPS STUDY CONTROLLED WITH ACTIVE COMPARATOR AND CARRIED OUT IN BLIND CONDITIONS TO EVALUATE THE SAFETY AND EFFICACY OF MK-966 (L-748, 731) IN PURCHASE WITH SODIUM DICLOFENACO IN PATIENTS WITH KNEE AND HIP OSTEOARTHRITIS
- Conditions
- -M139M139
- Registration Number
- PER-044-99
- Lead Sponsor
- MERCK SHARP & DOHME PERÚ S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 0
•Patient completed Protocol 034-10 per-protocol through Visit 19.0 (Treatment Week 104).
•Patient tolerated Protocol 034-10 study medication, and, in the opinion of the investigator and clinical monitor, demonstrated compliance with study procedures and study medication.
•Patient understands the study procedures and agrees to participate in the study by signing the informed consent document.
•Female patients of childbearing potential must demonstrate a urine (3-hCG level consistent with a nongravid state at Visit 19.0/21.0 and agree to remain abstinent or use oral contraceptives or use double-barrier contraception (partner using condom and patient using diaphragm, contraceptive sponge, or lUD) throughout the study and continuing at least 14 days after completion of treatment with study medication.
Patient experienced and/or was withdrawn from the study because of serious or clinically important adverse experiences during Protocol 034-10 as determined by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Safety will be monitored by repeated vital signs, physical examinations, and safety laboratory values. Female patients of childbearing potential also will be monitored by measuring urine b-hCG. Patient and investigator global evaluations and WOMAC VA 3.0, Section A., Question 1, (assessment of pain walking on a flat surface) will be solicited throughout the study as an indication of the patients overall clinical status. A radiograph of the study joint will be performed at treatment Week 156 or discontinuation from the study.<br>Measure:Safety<br>Timepoints:Duration of the Study<br>
- Secondary Outcome Measures
Name Time Method