None listed
Conditions
Interventions
Group 1 Type of group
60 mg of MK-0663 orally once a day for 86 weeks
Group name:Group 2 Type of group
500 mg of naproxen twice a day in a blind mode, double simulation for 86 weeks
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: Patient who experienced serious or clinically important adverse experiences and / or was withdrawn for the same cause during Parts I and II of the base protocol, as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Measure:Safety and tolerability Timepoints:When the adverse events appear | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The pain subscale (WOMAC VA 3.0) Measure:Presence of pain Timepoints:Administered at each visit, except for the post-study visit. ; 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. Measure:Global evaluation of the state of the disease by the patient and the researcher Timepoints:On each visit ; Outcome name:Measured according to the State of Health Survey SF-36. Measure:Quality of life Timepoints:On each visit | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed