PER-010-98已完成未知
A Randomized, Double Masked, Parallel Group, Placebo Controlled Outpatient Study to Examine the Safety, Tolerability and Efficacy of Single Oral Doses of Rizatriptan 10 mg and Naratriptan 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
- •Patient is between 18 and 65 years of age.
- •Patient has at least a 6-month history of migraine, with or without aura (Appendix 2).
- •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.
- •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.
- •Patient understands the procedures is literate has the ability to complete the diary and agrees to participate in the study.
排除标准
- •Patient is either pregnant (prestudy screening using serum B-HCG test) or a nursing mother.
- •Patient has a history (within 1 year) or current evidence of drug or alcohol abuse.
- •Patient has clinical or laboratory evidence of significant renal, gastrointestinal, pulmonary hepatic, endocrine, neurological (apart from migraine), or other systemic disease.
- •Patient has a history or clinical evidence of cardiovascular disease, e.g., myocardial infarction, stable or unstable angina, cerebrovascular accident or transient ischemic attack.
- •patient has clinically significant ECG abnormality, e.g., evidence of left bundle branch block (LBBB), myocardial infarction, or ischemia.
- •Patient has a resting systolic blood pressure of >160 mm Hg or diastolic of >95 mm Hg at screening.
- •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.
- •Patient has received treatment with an investigational device or compound within 30 days of the study.
- •Patient typically suffers from < 1 or > 8 attacks of migraine per month, has a preponderance of mild attacks, or has a basilar or hemiplegic migraine headache.
- •Patient has difficulty in distinguishing his/her migraine attacks from tension or interval headaches
- •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.
- •Patient is currently taking monoamine oxidase inhibitors or methysergide and is unable to tolerate withdrawal of any of these medications for the intervals required.
- •Patient has previousiy received rizatriptan or naratriptan.
研究者
相似试验
招募中
3 期
A Study of Ranibizumab in PatientsCTRI/2021/02/031050Intas Pharmaceuticals Ltd Biopharma Division
进行中（未招募）
1 期
Clinical study to compare efficacy and safety of Intas Ranibizumab with Lucentis.eovascular (Wet) Age-Related Macular Degeneration (AMD)MedDRA version: 27.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersEUCTR2021-001970-41-CZIntas Pharmaceuticals Ltd.546
进行中（未招募）
1 期
Clinical study to compare efficacy and safety of Intas Ranibizumab with Lucentis.eovascular (Wet) Age-Related Macular Degeneration (AMD)MedDRA version: 20.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersEUCTR2021-001970-41-LVIntas Pharmaceuticals Ltd.546
进行中（未招募）
1 期
Clinical study to compare efficacy and safety of Intas Ranibizumab with Lucentis.EUCTR2021-001970-41-PLIntas Pharmaceuticals Ltd.546
进行中（未招募）
1 期
A Randomized, Double-Masked, Parallel Group, Multi-center, Dose-Finding Comparison of the Safety and Efficacy of ASI-001A 0.5 µg/day and ASI-001B 0.2 µg/day Fluocinolone Acetonide Intravitreal Inserts to Sham Injection in Subjects with Diabetic Macular Edema - FAMEDiabetic Macular OedemaEUCTR2006-001035-22-PTAlimera Science Inc900