None listed
Conditions
Interventions
The main therapy will be supplied in tablets packed in blisters. Patients will either take a placebo, or MK-0663 120 mg once a day, or naproxen 500 mg twice a day, in a double-blind, placebo-controlled, double-dummy modality. Each morning, for 12 weeks, patients will take 3 tablets of the corresponding blister by mouth and 1 tablet each afternoon.
Group name:Placebo Type of group
The main therapy will be supplied in tablets packed in blisters. Patients will either take a placebo, or MK-0663 120 mg once a day, or naproxen 500 mg twice a day, in a double-blind, placebo-controlled, double-dummy modality. Each morning, for 12 weeks, patients will take 3 tablets of the corresponding blister by mouth and 1 tablet each afternoon.
Sponsors
MERCK SHARP & DOHME PERÚ S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age> = 18 years 2. The female patient must demonstrate a level of beta-HCG subunit in serum consistent with a non-pregnancy status at the pre-study visit and agree with sexual abstinence, or use a double barrier contraceptive method from at least 7 days prior to treatment and to continue for at least 14 days after Visit 7.0 or the discontinuation visit. Women who are in postmenopausal period or who have undergone hysterectomy or tubal ligation, are exempt from fulfilling this requirement 3. Confirmed clinical diagnosis of rheumatoid arthritis and is supposed to require treatment with nonsteroidal anti-inflammatory drugs for at least 3 months. 4. Diagnosis of rheumatoid arthritis carried out at least 6 months before the start of the study and not before 16 years of age. 5. The antirheumatic therapy was administered in stable form for 1 month (included antimalarials, azathioprine, oral or injectable gold salts, lefluonamide, methotrexate, sulfasalazine, oral corticosteroids or a solubilized TNF antagonist or antagonist of the TNF receptor). The patient must not have discontinued such therapy within the last month prior to the prescreening visit. 6. The patient is willing to avoid excess alcohol during the study 7. Except for their rheumatoid arthritis, the patient is considered as having good general health according to his / her medical history, physical examination and routine laboratory analysis. 8. In the opinion of the nurse / study coordinator and the investigator, the patient is willing to comply with the protocol and can do so. 9. The patient understands the study procedures and agrees to participate in it by giving written informed consent.
Exclusion criteria
Exclusion criteria: 1. The patient is legally or mentally disabled, has significant emotional problems at the time of the study, has a history of psychosis or is unable to give informed consent. 2. Arthropathic or concurrent clinical pathology, which could confuse or interfere with the control of the symptoms of rheumatoid arthritis. 3. History of esophageal, gastric, biliary or small bowel surgery (except for the simple closure of a perforation> 3 months prior to the study). This includes any gastrointestinal surgery that causes clinical malabsorption. Patients with a history of cholecystectomy> 3 months prior to the study are eligible. 4. The estimated creatinine clearance of the patient is 2.0 mg / dl. 5. The patient has angina pectoris or congestive heart deficiency, with symptoms that occur when resting or performing minimal activity, and / or has a history of myocardial infarction, coronary angioplasty, or coronary artery bypass graft within the last year . 6. Uncontrolled arterial hypertension. 7. History of stroke or transient ischemic attack within the last 2 years. 8. History of hepatitis / active liver disease within the last 2 years 9. History of neoplastic pathology 10. Shows evidence of occult gastrointestinal bleeding 11. History of diseases that, in the opinion of the researcher, could confuse the results of the study, constitute an additional risk for the patient, or contraindicate the chronic treatment with a DAINES such as naproxen 12. History of inflammatory bowel diseases. 13. In the initial endoscopy there is a gastric, esophageal and / or duodenal ulcer, or the patient shows a pyloric obstruction or esophageal erosions endoscopically evident 14. Bleeding diathesis or requires anticoagulant therapy. 15. Participation in a study with a drug under investigation within 4 weeks prior to entering the study 16. It is anticipated that it requires treatment with H2 receptor antagonists or proton pump inhibitors or that it requires other gastroprotective agents. 17. The patient will be excluded from the study if any of the following conditions apply: • Oral therapy with corticosteroids with more than the equivalent of 10 mg of prednisone daily and / or unstable doses for at least the month prior to selection; or current or future treatment with methotrexate at a dose> 25 mg per week. • Current or future treatment with a specific DAINES or inhibitor of COX-2 different from those of the study during the period of treatment of the same. • Current or future treatment with warfarin or other anticoagulants. • Current use of low dose ticlopidine, clopidrogel or aspirin (325 mg or less daily or every other day). • Intramuscular, intrathecal or intravenous use of corticosteroids for 1 month prior to entering the study. Intraarticular and oral corticosteroids are allowed during the study. 18. At the pre-study clinical examination or laboratory safety analyzes, the patient shows clinically significant abnormalities. 19. At present the patient is a user (including the recreational use) of any illicit drug, or has a history (within the last 5 years) of alcoholism or drug addiction. 20. The patient donated a unit of blood or plasma within the last 4 weeks. 21. The patient was previously exposed to MK-0663 in a clinical study. 22. The patient is allergic to a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Cumulative incidence of gastric and / or duodenal ulcers> 3 mm, either in the stomach or in the duodenum. An ulcer will be defined as a circumscribed rupture of the mucosa,> 3 mm in its greatest dimension (length), as measured by the close application of an open endoscopic biopsy forceps. The injury must also demonstrate an unequivocal depth. Measure:Accumulated incidence of gastric and / or duodenal ulcers Timepoints:At 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Accumulated incidence of gastric and / or duodenal ulcers> 5 mm in either the stomach or the duodenum Measure:incidence of gastric and / or duodenal ulcers> 5 mm Timepoints:At 12 weeks of treatment | — |
Countries
Canada, Peru, United States
Contacts
Public ContactStela López
MERCK SHARP & DOHME PERÚ S.R.L
Outcome results
None listed