None listed
Conditions
Interventions
Patients will take 2 tablets, 1 from the bottle labelled Bottle A and 1 from the bottle labelled Bottle B each morning by mouth without regard to food: 1 tablet will be matching placebo
Study group Type of group
Patients will take 2 tablets, 1 from the bottle labelled Bottle A and 1 from the bottle labelled Bottle B each morning by mouth without regard to food: 1 tablet will be MK-0966 50 mg
the second tablet will be matching placebo. Patients will take 1 tablet by mouth from the bottle labelled Bottle B in the evening without regard to food. This tablet will be matching placebo.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: - Patient is male or female, is at least 50 years of age or is at least 40 years of age and is taking chronic oral corticosteroids; and has a clinical diagnosis of rheumatoid arthritis and is judged by the investigator to require chronic NSAID therapy for at least 1 year. - Female patients must demonstrate a serum p-HCG level consistent with a nongravid state at the pre-study visit and agree to remain abstinent, use oral birth control pills or double-barrier contraception (partner using condom and patient using diaphragm, contraceptive sponge, or lUD) beginning at least 7 days prior to treatment and continuing at least 14 days after the End-of-Study Visit or a Discontinuation Visit. Women who are postmenopausal or status post hysterectomy or tubal ligation are exempt from this requirement. - Except rheumatoid arthritis, the patient is judged to be in otherwise general reasonable health, based on medical history, physical examination. and laboratory screening tests, enabling him or her to complete the trial without anticipated serious comorbid event. - Patient is able to understand and complete the study questionnaires - Patient understands the study procedures and agrees to participate in the study by giving written informed consent.
Exclusion criteria
Exclusion criteria: - Inflammatory arthritis (e.g., systemic lupus, spondyloarthropathy, polymyalgia rheumatica). Patients with a history of gout are allowed to enroll into the study; however, additional NSAID therapy will not be allowed for treatment of exacerbations during the course of the study. Patients with rheumatoid arthritis and secondary Sjogren’s disease or fibromyalgia are permitted to enter the study. - The patient is, in the opinion of the investigator, mentally or legally incapacitated such that informed consent cannot be obtained or the patient cannot read or comprehend written material. - The patient has a history of any illness or has significant abnormalities on pre-study clinical or laboratory evaluation that, in the Opinion of the investigator, contraindicates a 1- to 2-year course of therapy with a NSAID such as naproxen. - The patient has a documented history of ulcer or upper GI bleeding within the recent past which is felt by the investigator to mandate that NSAID therapy be given with concurrent proton-pump inhibitors, misoprostol or other medications not allowed per study protocol. - Patient has a history of gastric, biliary, or small intestine surgery that causes malabsorption. - The patient has evidence of impaired renal function, defined as estimated creatinine clearance 95 mm Hg or systolic blood pressure >165 mm Hg). - The patient has a history of stroke or transient ischemic attack (TIA) within the previous 2 years. (Note: If a patient has a TIA or stroke during the study they must be discontinued from the study.) - The patient has active hepatitis/hepatic disease. - Patient has a history of neoplastic disease. Patients with a history of leukemia, lymphoma, or myeloproliferative disease are ineligible for the study regardless of the time since treatment. Exceptions are: (a) patients with adequately treated basal cell carcinoma or carcinoma in situ of the cervix may participate, and (b) patients with other malignancies which have been successfully treated >5 years prior to screening, where in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of screening. - 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 acetaminophen, or has hypersensitivity (e.g., bronchoconstriction in association with nasal polyps) to aspirin, naproxen, and other NSAIDs. - Patient has morbid obesity and demonstrates significant health problems stemming from their obesity. - Positive result for the fecal occult blood screening test at baseline. - Patient has a history of esophageal or gastric surgery. (Patients with a history of simple closure of a perforation greater than 3 months prior to the beginning of th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The time-to-first-event data will be used to compare the incidence rates of FUBs between the group of patients taking MK-0966, 50 mg daily, and the group of patients taking naproxen 1000mg daily. Measure:Primary effectiveness criteria Timepoints:Throughout the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name: The numbers and proportions of patients who experience clinical or laboratory adverse experiences will be tabulated by type of adverse experience to assess the safety and tolerability of MK-0966 administered over the study period. Measure:Secondary effectiveness criteria Timepoints:Throughout the study. ; Outcome name:The time-to-first-event data will be also used to assess all binary variables. Patient and Investigator Global Assessments will be assessed as the average over the treatment period. Measure:Secondary safety criteria Timepoints:Throughout the study. ; Outcome name:The health care resource utilization data will be analysed by the Health Economics Group of BARDS Blue Bell. A separate document will be submitted to detail these Measure:Secondary effectiveness criteria Timepoints:Throughout the study. | — |
Outcome results
None listed