None listed
Conditions
Interventions
Group 1 Type of group
Patients will receive placebo daily for 12 weeks during part I of the study. The patients who received placebo in Part I will receive MK-0663 60 mg (50%) or naproxen (50%) in Part II during 40 weeks.
Group name:Group 3 Type of group
Patients will receive 1000 mg of Naproxen daily for 12 weeks during part I and 40 weeks during part II of the study.
Sponsors
MERCK SHARP & DOHME PERÚ S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: a. Patient is male or female, is at least 40 years of age, and has clinical diagnosis of osteoarthritis of the knee (tibio-femoral joint) or hip for greater than 6 months based on clinical and radiographic criteria. A newly diagnosed patient must have clinical symptoms consistent with osteoarthritis of the study joint for the past 6 months. b. Patient´s primary source of pain/disability is the lower extremity; if both knees and/or hips are affected, the most painful joint will be selected for evaluation for inclusion and clinical response. c. Female patient must demonstrate a serum p-hCG level consistent with a nongravid state at Visit 1.0 and agree to remain abstinent, or use double barrier contraceptives (partner using condom and patient using diaphragm, or IUD) beginning at least 7 days prior to Visit 1.0 and continuing at least 14 days after Visit 12.0 or a Discontinuation Visit. Women who are postmenopausal or status post hysterectomy or tubal ligation are exempt from this requirement. (Postmenopausal is defined as no menses for the previous 1 year. If cessation of menses is within 1 year, FSH must be documented as elevated into the postmenopausal range at Visit 1.0). d. Patient is of ARA functional Class I, II, or III e. Patient is willing to limit alcohol intake to 14 drinks a week and avoid unaccustomed strenuous physical activity (e.g., unaccustomed weight lifting, initiation of physical therapy) for the duration of the study and follow-up period. f. Excepting osteoarthritis, patient is judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests g. Patient is able to understand and complete study questionnaires including questions requiring a visual analog scale (VAS) response. h. Patient understands the study procedures and agrees to participate in the study by giving written informed consent. i. Patient is a regular user of NSAIDs and reports a past history of positive therapeutic benefít in osteoarthritis of the knee or hip with NSAID at a therapeutic dose level (Appendix 1) for at least 30 days prior to study enrollment. Regular use is defined as at least 25 of the previous 30 days. j. Patient assessment of pain walking on a flat surface at Visit 1.0 is less than 80 mm (100-mm VAS).
Exclusion criteria
Exclusion criteria: Patient has a concurrent medical/arthritic disease that could confound or interfere with evaluation of efficacy including, but not limited to: Inflammatory arthritis (e.g., rheumatoid arthritis, systemic lupus, spondyloarthropathy, polymyalgia rheumatica), gout, episodes of acute monoarticular arthritis clinically consistent with pseudogout, Paget´s disease affecting the study joint, a history of septic arthritis or intraarticular fracture of the study joint, osteochondritis dessicans or osteonecrosis of the study joint, Wilson´s disease, hemachromatosis, ochronosis, or primary osteochondromatosis. Patients with isolated patellofemoral disease manifested by primarily anterior knee pain, and the absence of tibiofemoral radiographic fíndings will be excluded from this study. b. Patient has a history of acute ligamentous or meniscal injury of the study joint within the previous 2 years or arthroscopy of the affected knee within 6 months prior to Visit 1.0. c. Patient is, in the opinión of the investigator, mentally or legally incapacitated preventing informed consent from being obtained, or cannot read or comprehend written material. d. Patient has a history of gastric, biliary surgery, or small intestina surgery that causes clinical malabsorption. Patient has a history of a signiñcant clinical or laboratory adverse event that in the Opinion of the investigator contraindicates a 1-year course of therapy with an NSAID such as naproxen. f. Patient´s estimated creatinine clearance [Men: (140-age) x weight (kg)/(serum creatinine (mg/dL) x 72); Women: (0.85) (140-age) weight (kg)/(serum creatinine (mg/dL) x 72)] is 10 years prior to screening, where in the judgment of both the investigator and treating physician, appropriate fóllow-up has revealed no evidence of recurrence from the time of treatment through the time of screening; (c) patients, who in the joint Opinión of the Clinical monitor and investigator, are unlikely to sustain a recurrence during the duration of the study]. k. Patient has a history of any illness that, in the opinión of the investigator, might confound the results of the study or pose additional risk to the patient. 1. Patient is currently a user (including recreational use) of any illicit drugs, or has a history of dmg or alcohol abuse within the past 5 years. m. Patient is allergic to paracetamol, or has hy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The pain subscale (WOMAC VA 3.0), Patient Global Assessment of Response to Therapy, and Investigator Global Assessment of Disease Status. Measure:Clinical Efficacy Timepoints:At Visits 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, and Discontinuation Visit (if patient discontinues). | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:To evaluate the safety and tolerability of MK-0663 administration for a I-year period. The following will be used: Physical examination, vital signs, body weight, electrocardiogram, laboratory safety studies—serum chemistry, CBC, urinalysis, uriñe, and serum P-hCG; the bone markers serum BSAP and serum CTX will be used in an exploratory analysis. Measure:Safety and tolerabiliiy Timepoints:Visit 1.0, Visit 12.0 or a Discontinuation Visit (if patient discontinúes). | — |
Contacts
Public ContactStela López
MERCK SHARP & DOHME PERÚ S.R.L
Outcome results
None listed