PER-011-98已完成未知
A Randomized, Double Blind, Parallel Group, Placebo Controlled Outpatient Study to Examine the Safety, Tolerability and Efficacy of Single Oral Doses of Rizatriptan 10 mg and Zolmitriptan 2.5 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: 1998年12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
- •1. Inclusion Criteria
- •a. Patient is between 18 and 65 years of age.
- •b. Patient has at least a 6-month history of migraine, with or without aura (Appendix 2).
- •c. Patient is male, or if female must be postmenopausal, surgically sterilized, or taking adequate contraceptive precautions. Any patient who is taking oral contraceptives must have received such agents for at least 2 months before entering the study.
- •d. Patient is judged to be in good health, apart from migraine, on the basis of a history and a physical examination carried out within 2 months prior to test treatment.
- •NOTE: For patients at risk of underlying coronary artery disease (CAD) (e.g., postmenopausal women, males over 40 years of age) and patients with risk factors for occult CAD (e.g., hypertension, hypercholesterolemia, diabetes, smokers, strong family history),
- •the investigator should consider additional cardiovascular assessment. Such assessment should be conducted only after the patient has met all other inclusion and exclusion criteria, and with the concurrence of the clinical monitor.
- •e. Patient understands the procedures, is literate, has the ability to complete the diary, and agrees to participate in the study.
排除标准
- •a. Patient is either pregnant (prestudy screening using serum B-HCG test) or a nursing mother.
- •b. Patient has a history (within 1 year) or current evidence of drug or alcohol abuse.
- •c. Patient has clinical or laboratory evidence of significant renal, gastrointestinal, pulmonary, hepatic, endocrine, neurological (apart from migraine), or other systemic disease.
- •d. Patient has a history or clinical evidence of cardiovascular disease, e.g., myocardial infarction, stable or unstable angina, cerebrovascular accident or transient ischemic attack.
- •e. Patient has clinically significant ECG abnormality, e.g., evidence of left bundle branch block (LBBB), myocardial infarction.
- •f. Patient has a resting systolic blood pressure of >160 mm Hg or diastolic of >95 mm Hg at screening.
- •g. Patient has a history of any disease that in the opinion of the investigator may confound the results of the study or pose an additional risk.
- •h. Patient has received treatment with an investigational device or confound within 30 days of the study.
- •i. Patient typically suffers from <1 or >8 attacks of migraine per month, has a preponderance of mild attacks, or has basilar or hemiplegic migraine headaches.
- •j. Patient has difiicuity in distinguishing his/her migraine attacks from tension or interval headaches.
- •k. Patient has either demonstrated hypersensitivity to or experienced a serious adverse event in response to any marketed or investigational 5HT 1B/1D receptor agonist (oral or subcutaneous), or has any contraindication to its use.
- •l. Patient is currently taking monoamine oxidase inhibitors or methysergide and is unable to tolerate withdrawal of any of these medications for the intervals required. (See Section E.2.b.
- •for appropriate withdrawal periods.)
研究者
相似试验
进行中（未招募）
不适用
A Randomized, Double Blind, Parallel Group, Placebo Controlled 28 Day Study to Investigate the Safety, Tolerability and Pharmacodynamics of SB-656933 in Patients with Cystic FibrosisCystic fibrosisEUCTR2010-018738-27-DEGlaxoSmithKline Research & Development Limited100
已完成
不适用
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injection for Post-operative Pain following Laparoscopic-assisted Gastrectomy in Early Gastric Cancer PatientsKCT0001620Vivozon60
进行中（未招募）
1 期
A study to identify whether it is safe, if it works, and how much and how often cysteamine should be given to adult patients with Cystic Fibrosis (CF) who are being treated for a worsening of CF associated lung disease.exacerbation of Cystic FibrosisMedDRA version: 19.0Level: PTClassification code 10070608Term: Infective pulmonary exacerbation of cystic fibrosisSystem Organ Class: 10021881 - Infections and infestationsEUCTR2015-004986-99-ITovaBiotics, Ltd120
进行中（未招募）
1 期
A study to identify whether it is safe, if it works, and how much and how often cysteamine should be given to adult patients with Cystic Fibrosis (CF) who are being treated for a worsening of CF associated lung disease.exacerbation of Cystic FibrosisEUCTR2015-004986-99-GBovaBiotics, Ltd120
终止
不适用
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injection for Post-operative pain following Total Hip ArthroplastyDiseases of the musculoskeletal system and connective tissueKCT0002653Vivozon20