Double Blind Extension Study, Controlled with Active Comparator of 86 Weeks Duration of a 2-Part Study, Double Blind, Parallel Group, Placebo Controlled and Active Comparator to Evaluate the Safety and Efficacy of MK-0663 versus Naproxen in Patients Suffering Osteoarthritis
- Conditions
- -M199M199
- Registration Number
- PER-047-01
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• The patient enrolled in Protocol 019 (base protocol) of MK-0663 and concluded Parts I and n according to the protocol until Visit 12.0 (Treatment Week 52).
• The patient meets all the inclusion criteria for Protocol 019 (base protocol) of MK-0663. (Note: If the patient did not meet all the entry criteria, but was included by a specific exception approved by Merck, the patient can also be enrolled in this extension).
• The patient tolerated the medicine from the baseline study and, in the opinion of the investigator and the clinical monitor, demonstrated compliance with the study procedures and medication.
• The patient understands the study procedures and agrees to participate in the study by signing the informed consent.
• Patients of childbearing age should demonstrate a b-hCG level in urine consistent with the non-pregnant state in Visit 12.0 / 14.0 and agree to follow a period of abstinence or use double-barrier contraceptives (the couple using a condom and the patient´s diaphragm) , contraceptive sponge or DTTT) during the study and until at least 14 days after the conclusion of treatment with the study medication.
Patient who experienced serious or clinically important adverse experiences and / or was withdrawn for the same cause during Parts I and II of the base protocol, as determined by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:By means of counts and percentages of patients in each treatment group with adverse experiences and with laboratory values that exceed the predefined limits.<br>Measure:Safety and tolerability<br>Timepoints:When the adverse events appear<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:The pain subscale (WOMAC VA 3.0)<br>Measure:Presence of pain<br>Timepoints:Administered at each visit, except for the post-study visit.<br>;<br>Outcome name:Global Assessment of the State of the Disease by the Patient on a visual analog scale (VAS) and Global Assessment of the State of the Disease by the Investigator on a Likert scale.<br>Measure:Global evaluation of the state of the disease by the patient and the researcher<br>Timepoints:On each visit<br>;<br>Outcome name:Measured according to the State of Health Survey SF-36.<br>Measure:Quality of life<br>Timepoints:On each visit<br>