None listed
Conditions
Interventions
Group 1 Type of group
21 mg of L-001069957 plus 100 mg of aspirin EC once a
day
Group name:Group 4 Type of group
100 mg of EC aspirin once a day
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient is male or female. • The patient is> 45 years of age. • The patient has been clinically diagnosed with osteoaitritis (OA) or rheumatoid arthritis (RA) at least 6 months before Visit 1.0. • Patient 1) is not in chronic therapy with aspirin or 2) is in chronic therapy with aspirin • Patient 1) is not receiving a GPIIb / IIIa inhibitor (for example, • ticlopidine), or 2) is receiving a GPIIb / IIIa inhibitor and meets the criteria specified below: • The patient reports a history of positive therapeutic benefit with NSAIDs or COX-2 inhibitors in the past, and at the investigator´s discretion, the patient will require chronic therapy with NSAIDs or a selective COX-2 inhibitor for at least 3 months . • The patient is not pregnant or breastfeeding, and is not planning a pregnancy within the scheduled duration of the study. • The patient is willing to avoid excess alcohol during the study (ie, will not consume more than 2 doses per day [8 ounces of beer, 4 ounces of wine, 1 ounce of liquor]). • The patient is willing to avoid strenuous, unaccustomed physical activity (for example, lifting unaccustomed weight, initiation of physical therapy) during the study and the follow-up period. • With the exception of osteoarthritis or rheumatoid arthritis, the patient is considered otherwise to have a general stable state of health based on medical history, physical examination, and routine laboratory tests. • According to the criteria of the nurse / study coordinator and the researcher, the patient is willing and able to comply with the protocol. • The patient understands the study procedures and agrees to participate in the study by providing written informed consent.
Exclusion criteria
Exclusion criteria: • The patient is mentally or legally incapacitated. • The patient has a concurrent medical / arthropathic disease that could confuse or interfere with the control of the patient´s osteoarthritis or rheumatoid arthritis symptoms with the study therapy including, but not limited to: Systemic lupus erythematosus, spondyloarthropathy, polymyalgia rheumatica, arthritis psoriatic, ochronosis, pseudogota, or Paget´s disease. • The patient has a history of esophageal, gastric, biliary, or small bowel surgery (except for the simple closure of a perforation performed more than 3 months before the study). This includes hiatal hernia surgeries and any gastrointestinal surgery that produces clinical malabsorption or delayed gastric emptying. • The patient has uncontrolled hypertension, defined as systolic blood pressure> 165 mm Hg or diastolic blood pressure> 95 mm Hg. • The patient has uncontrolled diabetes. • The patient has unstable angina, angina at rest or with minimal activity. • The patient has suffered one of the following conditions or procedures within the last 6 months: myocardial infarction, stable angina, coronary angioplasty, stenting, coronary artery bypass graft. • The patient has a diagnosis of congestive heart failure-with symptoms that occur at rest or with minimal activity. • The patient has a prolonged QTc interval in a previous ECG, in the ECG of the screening in Visit 1.0, or has a history of prolonged QT syndrome. • The patient has had a stroke, a transient ischemic attack (TTA), or a ´carotid endarterectomy within the last year. • The patient has a history of hepatitis / liver disease that has been active within the past 2 years. • The patient has a history of neoplastic disease in the last 5 years and is not among the exceptions mentioned below. If the patient has a history of leukemia, lymphoma, or myeloproliferative disease, then he is not eligible for the study, regardless of the time since treatment, and in such cases, no exceptions will be applied. • The patient has evidence of occult GI bleeding documented by any of the 3 stool Hemoccult tests that were obtained and read before the baseline endoscopic examination. • The patient has a history of any disease that, in the opinion of the investigator, could confuse the results of the study, pose an additional risk to the patient, or contraindicate treatment with aspirin or a selective inhibitor of COX-2 such as celecoxib or rofecoxib (Appendices 1 and 2). If any questions arise, the Merck clinical monitor will be consulted. • The patient has significant findings in the physical examination that, in the investigator´s judgment, could confuse the results of the study, pose an additional risk to the patient, or contraindicate treatment with aspirin or a selective COX-2 inhibitor. as celecoxib or rofecoxib. • The patient has a history of inflammatory bowel disease. • A gastric, esophageal, and / or duodenal ulcer is present in the basal endoscopy at Visit 2.0, or the patient has a pyloric obstruction evident by endoscopy. • The patient has erosive esophagitis in the basal endoscopy at Visit 2.0 (ie, patients without mucosal abnormalities, without macroscopic erosions, but erythema, hyperaemia, or mucosal friability can be taken into account for enrollment). • The patient has a bleeding diathesis. • The patient will be excluded from the study if the patient is expected to require treatment with H2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:An ulcer will be defined as a circumscribed break in the mucosa> 3 mm in its widest dimension (length), measured by the meticulous application of an open endoscopic biopsy forceps Measure:Cumulative incidence of gastric and / or duodenal ulcers> 3 mm in the stomach or duodenum during the treatment period. Timepoints:During treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Change with respect to basal in the number of erosions in the gastric and duodenal mucosa Measure:Change with respect to basal in the number of erosions in the gastric and duodenal mucosa Timepoints:During treatment ; Outcome name:Concomitant use of acetaminophen / paracetamol and antacids Measure:Concomitant use of acetaminophen / paracetamol and antacids Timepoints:During treatment | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed