PER-067-00已完成未知
Multicenter, Randomized, Double Blind, Parallel Group, Controlled with Placebo and Active Study, Carried Out Under Internal Blind Conditions whose Purpose is to Determine the Incidence of Gastroduodenal Ulcers in Patients Suffering from Osteoarthritis after 12 Weeks of Placebo Treatment, Low Dose of Aspirin, MK-0966 plus Low Dosage of Aspirin or Ibuprofen.
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2000年1月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •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.
排除标准
- •The patient is <50 years old, mentally or legally incapacitated or unable to give informed consent.
- •The patient requires aspirin therapy at any concentration or other forms of antiplatelet therapy, either prophylactically or by any medical condition.
- •The patient has a medical / arthropathic disease that could confuse or interfere with the control of the patient´s osteoarthritis symptoms with the study therapy that includes, without limitation: Rheumatoid arthritis, systemic lupus erythematosis, 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 closure of a perforation greater than 3 months prior to the study).
- •The estimated creatinine clearance of the patient is <30 mL / min
- •The patient suffers from uncontrolled hypertension [Note: Patients with medically controlled hypertension (diastolic blood pressure <95 mm Hg, systolic blood pressure <165 mm Hg) can participate.]
- •The patient has experienced a stroke or transient ischemic event; myocardial infarction; angina (stable or unstable) or congestive heart failure with symptoms during rest or minimal activity; coronary angioplasty, coronary artery bypass graft or endarterectomy.
- •The patient has a history of hepatitis / liver disease that has been active for the past 2 years. It is necessary that patients with serum ALT or AST> 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.
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