None listed
Conditions
Interventions
MK-0663 120 mg administered orally once a day for 12 weeks
Group name:Placebo Type of group
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient must have a confirmed diagnosis of osteoarthritis, and is expected to require treatment for 3 months. • The patient is male or female and age 50 or older. • The female patient must demonstrate a level of p-HCG subunit in serum consistent with a non-pregnancy status at the pre-study visit, and agree to abstain from abstinence, or use a double-barrier method of contraception • (the couple uses a condom and the patient´s diaphragm, contraceptive sponge, spermicide, or IUD), since at least 7 days prior to treatment, and also agrees to continue for at least 14 days after Visit 7.0 or the discontinuation visit. Women who are in the postmenopausal period or who have undergone hysterectomy or tubal ligation, are exempt from complying with this requirement (Postmenopausal is defined as without menstruation during the last previous year.) If the end of menstruation is within 18 months prior to the study, the level of FSH raised to the postmenopausal range should be documented in the pre-study). • The patient is willing to avoid excess alcohol during the study • Except for your osteoarthritis, the patient is considered stable general health according to your medical history, physical examination and routine laboratory analysis • In the opinion of the nurse / study coordinator and the researcher, the patient is willing to comply with the protocol and can do so. • The patient understands the study procedures and agrees to participate in it by giving written informed consent.
Exclusion criteria
Exclusion criteria: • The patient is under 50 years of age, is legally or mentally incapacitated, or is unable to give informed consent. • The patient presents a concurrent arthropathic / clinical pathology, which could confuse or interfere with the control, through study therapy, of the symptoms of osteoarthritis, which includes, but is not limited to them; systemic lupus erythematosus, spondyloarthropathy, polymyalgia rheumatica, psoriatic arthritis, ochronosis, pseudogout, or Paget´s disease. Note: Patients with a history of gout are allowed to enter this study, however, no additional therapy with NSAID will be allowed to treat exacerbations during the course of the study. • The patient has a 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. • The estimated creatinine clearance of the patient is less than or equal to 30 ml / min, • The patient presents with 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. • The patient is hypertensive uncontrolled. [Note: Patients with controlled high blood pressure can participate (diastolic blood pressure <95 mm Hg, systolic blood pressure <165 mm Hg).] • The patient has a history of stroke or transient ischemic attack within the last 2 years. • The patient has a history of hepatitis / active liver disease within the last 2 years. • The patient has a history of neoplastic diseases and does not meet any of the following exceptions. If the patient has a history of leukemia, lymphoma or myeloproliferative pathologies, they will not be eligible for this study, regardless of the time elapsed since treatment. In the latter case, no exception will be applied. • The patient shows evidence of occult gastrointestinal hemorrhage as documented by any of the three Hemoccult analyzes on fecal matter obtained and analyzed prior to patient distribution. • The patient has a history of diseases that, in the opinion of the investigator, could confuse the results of the study, constitute an additional risk for the patient, or contraindicate the treatment with an NSAID such as ibuprofen. • The patient has a history of inflammatory bowel diseases. • In the initial endoscopy there is a gastric, esophageal, and / or duodenal ulcer, or the patient shows a pyloric obstruction or endoscopically evident esophageal erosions • The patient has a bleeding diathesis or requires anticoagulant therapy. • The patient participated in a study with a drug under investigation within 4 weeks of entering the study. • Prior or Concomitant Medication • The patient will be excluded from the study if it is expected to require treatment with H2 receptor antagonists (eg, cimetidine, ranitidine, famotidine, nizatidine) or with proton pump inhibitors (eg, omeprazole, lansoprazole) due to a condition chronic related to acidity (eg, acid reflux, gastroesophageal acid), or that requires other gastroprotective agents (eg, carafate, sucralfate). If a Ha receptor antagonist or a proton pump inhibitor has been administered at a dose exceeding that recommended in t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The patient will offer a Global Assessment of the Condition of the Disease in each of the visits by selecting a classification of the following scale: Considering all the ways in which your arthritis affects you, check a box with a (X) to show how well you are doing. 0 = Very good 1 = Good 2 = Regular 3 = Bad 4 = Very bad Measure:Efficacy Timepoints:During treatment ; Outcome name:Measure the number of patients who present remission of symptoms at the end of treatment Measure:Incidence Timepoints:At the end of treatment | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed