PER-062-01已完成未知
A RANDOMIZED, MULTINATIONAL, DOUBLE-BLIND, PLACEBO-CONTROLLED AND PARALLEL-GROUP ACTIVE COMPARATOR STUDY TO EXAMINE THE SAFETY, TOLERABILITY AND EFFICACY OF ROFECOXIB OF 50 AND 25 MG FOR THE ACUTE TREATMENT OF MIGRAINE
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2001年10月5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
- •The patient is 18 years old, as the minimum age.
- •The patient has had on average> 1 and <8 migraine attacks per month during the last 6 months, with or without aura
- •The patient understands the study procedures and agrees to participate in the study by giving written informed consent.
排除标准
- •The patient has difficulty distinguishing his migraine attacks from headaches caused by tension or at intervals.
- •If a woman, if the patient is pregnant or breastfeeding, or if she is of childbearing age and is sexually active, she is not willing to use effective oral contraceptives or oral contraceptives during the study. Patients who are taking oral contraceptives and have done so for less than 2 months before entering the study.
- •The patient has shown hypersensitivity, or has experienced an adverse event in response to rofecoxib or ibuprofen, or has a contraindication to the use of rofecoxib or ibuprofen (eg, allergic reaction to NSAIDs)
- •The patient has clinical or laboratory evidence of uncontrolled hypertension, or pulmonary, renal, hepatic, endocrine, neurological (other than migraine), psychiatric or systemic disease, or any laboratory abnormality that, in the opinion of the investigator, may confuse the results of the study, represent an additional risk to the patient or interfere with optimal participation in the study.
- •The patient has a history of alcohol or drug abuse within 1 year.
- •The patient has received treatment with an experimental device or compound within 30 days of the study.
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