PER-042-02已完成未知
A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Etoricoxib 60 mg and Diclofenac Sodium 150 mg in Patient With Osteoarthritis of the Knee or Hip
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2002年6月21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
入选标准
- •a. The patient is male or female, at least 40 years of age, and has a clinical and radiographic diagnosis of osteoarthritis of the knee (tibiofemoral joint) or hip.
- •b. The patient is diagnosed as Class I, II or III functional of 4 classifications of the American College of Rheumatology
- •c. The patient has a history of positive therapeutic benefit in knee or hip osteoarthritis with NSAIDs previously obtained
- •d. The patient regularly takes a single NSAID, at a prescription concentration, for at least 30 days before admission.
- •e. The assessment of the patient´s walking on a flat surface pain (WOMAC Osteoarthritis Index Version VA 3.0, Question 1) at the Screening visit is <=80 mm on the 100 mm VAS scale.
- •F. Prior to randomization and discontinuation of previous therapy with NSAIDs during the washout period. The patient meets the following criteria for joint crisis, in its entirety, in Visit 2 (joint crisis visit):
- •Minimum 40 mm in the evaluation of pain when walking on a flat surface by the patient on the VAS 100 mm scale.
- •Increase of at least 15 mm in the evaluation of pain when walking on a flat surface on the part of the patient in comparison with the results of the selection recorded in Visit 1; Y
- •A worsening in the Global Assessment of the State of Illness by the Investigator of at least 1 point on a 5-point Likert scale compared to the evaluation of the selection registered in Visit 1.
- •g. For patients of childbearing age: the patient presents a level of human chorionic gonadotropin of urine beta type compatible with a non-pregnant state in the Selection and Basal Visits 1 and 2, and agrees to use an appropriate method of double barrier contraception or abstinence from sexual contact for at least 7 days before treatment, continuing during the treatment period or until a discontinuation visit.
- •h. Limit alcohol intake to no more than 7 drinks per week and avoid unusual strenuous physical activity for the duration of the study.
排除标准
- •a. Simultaneous medical / arthritic disease that could confuse or interfere with the evaluation of efficacy.
- •b. The patient has chondrocalcinosis, except if incidental chondrocalcinosis, which differs from the pseudogout by 1) age> 65 years, 2) without polyarthritis, 3) without prior diagnosis of pseudogout, and 4) in the opinion of the doctor, there is no pseudogout in the patient.
- •c. The patient has isolated patellofemoral disease that manifests mainly through pain in the anterior knee.
- •d. The patient has a history of acute ligament or meniscal injury of the study joint within the previous 2 years or arthroscopy of the affected study joint within 6 months prior to entering the study.
- •e. The patient is a candidate for imminent joint replacement.
- •F. In the opinion of the researcher, the patient is mentally or legally incapacitated
- •g. The patient has a history of gastric or biliary surgery or small bowel surgery that causes clinical malabsorption.
- •h. The patient has clinical or laboratory evidence of significant renal, gastrointestinal, pulmonary, liver, endocrine, neurological (apart from migraine) or other systemic disease that the investigator says contraindicates a 6-week NSAID therapy.
- •i. The patient´s serum creatinine is greater than 2.0 mg / dL (2 mg / dL or greater than 176.8 micromol / L).
- •j. The patient has angina or congestive heart failure with symptoms that occur while at rest or when performing activity
- •k. The patient has uncontrolled hypertension.
- •1. The patient has a recent history of stroke or transient ischemic attack (within the previous 2 years).
- •m. The patient is currently a user (including the recreational use) of any drug not allowed, or has a history of drug or alcohol abuse within the previous 5 years.
- •n. The patient is allergic (asthma induced by NSAIDs, urticaria or other allergic-type reactions) to paracetamol, or hypersensitive (for example, bronchoconstriction associated with nasal polyps) to aspirin or another NSAID.
- •o. The patient has a history of neoplastic disease
- •p. The patient has a history of a disease that, in the opinion of the researcher, may confuse the results of the study or pose an additional risk to the patient
- •q. Intravenous, intramuscular or oral corticosteroids were administered to the patient within 30 days prior to randomization.
- •r. The patient was administered intra-articular steroids, Hyalgan® (sodium hyaluronate), or Synvisc® (hilane GF 20) for the study joint within 3 months of enrollment or intra-articular steroids, Hyalgan®, or Synvisc® for any other articulation within 30 days prior to randomization.
- •s. The patient has been taking glucosamine and / or chondroitin sulfate for <6 months before the start of the study.
- •t. The patient is using topical, oral medications or systemic analgesics (other than current NSAIDs) that may interfere with efficacy evaluations.
- •or. The patient is taking warfarin, clopidogrel bisulfate (Plavix®), rifampicin, antiepileptic drugs, muscle relaxants, or high-dose aspirin.
- •V. Patient dosing of the concomitant medication for a chronic disease / condition has changed within 30 days prior to Visit 1 or is expected to change during the 6 week treatment period of this study.
- •w. The patient presents clinically significant abnormalities in the Screening Visit 1, the clinical examination or the laboratory safety tests
- •X. The patient has participated in a previous stu
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