EUCTR2008-004095-43-FR进行中（未招募）1 期
A Phase IIa Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled, Clinical Trial to Study the Efficacy and Safety of MK-0974 Co-administered with Ibuprofen or Acetaminophen in Patients with Migraine With or Without Aura
aboratoires Merck Sharp & Dohme-Chibret0 个研究点目标入组 640 人开始时间: 2008年10月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 640
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.=18 years of age
- •2.History of migraine with or without aura > 1 year
- •3.=1 and =8 migraine days per month in the last 2 months that typically last from 4 to 72 hours untreated.
- •4.Willing to stay awake for at least 2 hours after administration of study medication
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.> 50 years old at age of migraine onset. Difficulty distinguishing migraine from other headaches
- •2.Predominantly mild migraine attacks or attacks that usually resolve spontaneously in < 2 hours
- •3.Basilar or hemiplegic migraine headache.
- •4.> 15 headache-days/month or has taken medication for acute migraine or other headache on > 10 days/month in last 3 months.
- •5.Changed dose of prophylactic medication in last 3 months
- •6.Within 3 months of screening, has had myocardial infarction, unstable angina, coronary artery bypass surgery or other revascularization procedure, stroke, or transient ischemic attack.
- •7.Uncontrolled hypertension (> 160/100 mm Hg), uncontrolled diabetes, HIV disease, or significant pulmonary, renal, hepatic, endocrine, or other systemic disease
- •8.Malignancy = 5 years prior to signing consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or prostate cancer.
- •9.History of gastric or small intestinal surgery, or disease that causes malabsorption.
- •10.Hypersensitivity to or previous SAE in response to ibuprofen or acetaminophen.
- •11.Other confounding pain syndromes (i.e., condition requiring daily use of opioids), psychiatric condition such as major depression based on the criteria such as DSM-IV, dementia or significant neurological disorders other than migraine
- •12.Any clinically significant disease that might confound the results of the study, complicate the interpretation of the study results, interfere with the patient’s participation for the full duration of the study, or pose an additional undue risk to the patient.
- •13.Score =2 on item 9 of the PHQ-9
- •14.Patient has taken any of the following medications in the time frame specified:
- •Time Frame 1 month prior to screening (and also prohibited throughout the study period)
- •Potent CYP3A4 inhibitors
- •cyclosporine, itraconazole, ketoconazole,, erythromycin, clarithromycin, telithromycin, nefazodone, HIV protease inhibitorsPotent CYP3A4 inducers
- •rifampicin, rifabutin, carbamazepine, phenytoin, barbiturates, systemic glucocorticoids, nevirapine, efavirenz, pioglitazone, primidone, St. Johns wort
- •Specific CYP3A substrates
- •astemizole, cisapride, pimozide, terfenadine
- •Concomitant use of other CYP3A4 substrates is permitted with caution (e.g., theophylline, ergot derivatives)
- •Concomitant use of other CYP3A4 and P-gp substrates is permitted, however, these medications should be administered with appropriate caution due to the potential for drug-drug interaction (e.g. quinidine, theophylline, ergot derivatives).
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