None listed
Conditions
Interventions
MK-0966 12.5mg will be administered once a day orally for six weeks.
Group name:Arthrotec Type of group
Arthrotec ™ (50mg diclofenac / 200mcg misoprostol) will be administered one tablet twice a day orally for 6 weeks.
Sponsors
MERCK SHARP & DOHME PERÚ S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • Patient is male or female, is at least 40 years of age, and has an established clinical diagnosis of osteoarthritis requiring treatment. During the month previous to Visit 1, the patient must have had pain in the affected joint on motion or weight bearing for the majority of days which was at least partially relieved by rest. • Female patients must demonstrate a serum b-hCG level consistent with a nongravid state at the prestudy visit and agree to either remain abstinent, use oral birth control pills or mechanical-barrier contraception (partner using condom or patient using diaphragm, contraceptive sponge or intra-uterine device) beginning at least 7 days prior to treatment and continuing at least 14 days after Visit 5 or the discontinuation visit. Women who are postmenopausal or have been hysterectomized or have undergone tubal ligation are exempt from this requirement. (Postmenopausal is defined as no menses for the previous year. If cessation of menses is within one year, FSH must be documented as elevated into the postmenopausal range before the start of the study). • The patient is willing to limit alcohol intake to 14 drinks a week and to avoid unaccustomed strenuous physical activity (e.g., unaccustomed weight lifting, initiation of physical therapy) for the duration of the study and follow-up period. • Excepting osteoarthritis, the patient is judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests (Appendices 2 & 3). • The patient is able to understand and complete study questionnaires including questions requiring a visual analog scale (VAS) response. • The patient understands the study procedures and agrees to participate in the study by giving written informed consent.
Exclusion criteria
Exclusion criteria: Previous Arthritis History • Patient has a concurrent medical/arthritic disease that could confound or interfere with monitoring of efficacy including, but not limited to: • Inflammatory arthritis (e.g., rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthropathy, Reiter´s syndrome [reactive arthritis], ankylosing spondylitis, arthritis associated with inflammatory bowel disease, 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 dessiccans or osteonecrosis of the study joint, Wilson´s disease, hemochromatosis, ochronosis, or primary osteochondromatosis. • Patient has a history of acute injury of the study joint within the previous year. Other Concurrent/Previous Medical Conditions; • Patient is, in the opinion of the investigator, mentally, or legally incapacitated preventing informed consent from being obtained, or cannot read or comprehend written material. • Patient has a history of a significant clinical or laboratory adverse event that in the opinion of the investigator contraindicates a 6-week course of therapy with NSAID such as Arthrotec™. • 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 95 and/or systolic blood pressure >165). • Patient has any condition that causes diarrhea or increases its incidence including but not limited to chronic or acute inflammatory gastrointestinal disorders, malabsorption and infectious diseases. • Patient has a history of gastric, biliary or small intestinal surgery that results in clinical malabsorption. • Patient has uncontrolled diabetes mellitus, renal disease, stroke or neurological disorder, cardiovascular, hepatic or neoplastic disease (patients with adequately treated skin cancer or carcinoma in situ of the cervix may participate; patients with a history of adequately treated neoplastic disease without evidence of recurrence for a minimum of 1 year may participate), or any other disease that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient. • Patient has any personal or family history of an inherited bleeding disorder. • Patient is currently a user (including recreational use) of any illicit drugs, or has a history of drug or alcohol abuse within the past 5 years. • Patient is allergic to paracetamol, or has hypersensitivity (e.g., bronchoconstriction in association with nasal polyps) to aspirin, naproxen, indomethacin and other NSAID. [Note: • Patients with a history of a potential idiosyncratic allergic reaction (e.g., rash) to a single NSAID in the past but who tolerate at least two other NSAID without hypersensitivity reactions may participate.] • Patient has morbid obesity and demonstrates significant health problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:A patient global assessment of disease status on a visual analog scale (VAS) will be administered. An investigator global assessment of disease status on a Likert scale will be recorded. Measure:Efficacy Timepoints:On visits 1, 2, 3, 4 and 5 (or the interruption visit). ; Outcome name:Record of adverse experiences, blood pressure, pulse, CBC, chemical serum panel, urinalysis, hemoglobin, hematocrit, electrocardiogram, stool blood cultures. Measure:Safety Timepoints:Adverse experíences will be monitored throughout this study and such events will be recorded. Blood pressure and pulse will be measured at all visits. A CBC, serum chemistry panel, and urinalysis will be obtained at visits 1 and 5 or at discontinuation. Hemoglobin and hematocrit will be measured at all visits. A 12-Iead electrocardiogram will be obtained at Visit 1. Stool Hemocults will obtained at visit 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Drop outs due to toxicity will be assessed by use of Fishers exact test and patient and investigator global assessment of disease status. Measure:Drop out due to adverse events Timepoints:The 6 weeks that the study lasts | — |
Contacts
Public ContactStela López
MERCK SHARP & DOHME PERÚ S.R.L
Outcome results
None listed