None listed
Conditions
Interventions
Placebo for 25 mg de MK-0966 for 12 weeks
Group name:Grupo IV Type of group
Dosage of 800 mg of ibuprofen 3 times a day for 12 weeks
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient must have an established diagnosis of osteoarthritis and require a treatment of 3 months. • Man or woman of> 50 years. (Patients who turn 50 during the course of the -16 weeks of the study may participate, younger patients may not be enrolled in the study). • If the patient is female, must demonstrate a level of serum b-HCG consistent with a non-pregnant state in the pre-study visit and agree to remain abstinent or use contraceptives from a single barrier (partner with condom or patient with diaphragm, contraceptive sponge) , spermicide or IUD) that starts at least 7 days before treatment and continues at least 14 days after Visit 7.0 or a discontinuation visit. If the patient is postmenopausal or has undergone a hysterectomy or tubal ligation, she will be exempt from this requirement. (Postmenopause is defined as the lack of menstruation during the previous year.) If cessation of menstruation has occurred within the last 18 months, follicle-stimulating hormone [FSH] should be documented during the pre-study period as high in the postmenopausal range.) • The patient wishes to avoid excess alcohol during the study (ie, will not consume more than 2 drinks [8 oz of beer, 4 oz of wine, 1 oz of liquor, per day]. • Except for osteoarthritis, the patient is considered to have stable health based on his medical history, physical examination and routine laboratory tests • In the opinion of the study nurse / coordinator, the patient wants and is able to comply with the protocol. • The patient understands the study procedures and agrees to participate in the study by giving written informed consent.
Exclusion criteria
Exclusion criteria: • The patient is 1.5 times the upper limit of the normal range deal with the Merck medical monitor before randomization. • The patient has a history of a neoplastic disease in the previous 5 years and does not meet any of the exceptions listed below. If the patient has a history of leukemia, lymphoma or myeloproliferative disease, they will not be able to participate in the study regardless of the time since treatment, and in such cases, there will be no exceptions. • Patient shows evidence of occult gastrointestinal bleeding as documented by 1 of 3 Hemoccult fecal tests obtained and evaluated prior to selection. • The patient has a history of a disease that, in the opinion of the investigator, could confuse the results of the study, put the patient at additional risk, or contraindicate the treatment with an NSAID such as ibuprofen. • The patient has a history of inflammatory bowel disease. • There is evidence of gastric, esophageal and / or duodenal ulcer in the initial endoscopy or the patient has an endoscopically evident pyloric obstruction or erosive esophagitis. • The patient has bleeding diathesis or requires anticoagulant therapy. • The patient has participated in a study with investigational drugs within 4 weeks prior to this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Endoscopies will be used to determine the primary end point that will be the development of a gastric and / or duodenal ulcer, defined as damage circumscribed to the mucosa, at least 3 mm in its greatest dimension (length), with a clear depth. Measure:Cumulative Incidence of Gastric and / or duodenal Ulcers of >3 mm Timepoints:In the baseline, week 6 and week 12, or at the time of discontinuation | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Vital signs, weight, blood biochemistry, count of blood cells with differential and platelet count, urine analysis, electrocardiogram, serum b-hCG (women of childbearing age only), and Hemoccult in feces. Measure:Safety and Tolerability Timepoints:On weeks 1, 3, 6, 9 y 12 ; Outcome name:Endoscopy Measure:Cumulative incidence of gastric and / or duodenal ulcers > 5 mm Timepoints:Week 1, 6 and 12 | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed