NCT00300924已完成3 期
A Double-Blind, Double-Dummy, Randomized, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of Rizatriptan 10mg Co-Administered With Acetaminophen for the Treatment of Acute Migraine.
Diamond Headache Clinic13 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2006年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 13
- 主要终点
- To compare the efficacy of rizatriptan co-administered with acetaminophen to placebo, acetaminophen and rizatriptan for the acute treatment of migraine, as measured by the percentage of patients with pain relief at 2 hours.
研究概览
简要总结
The purpose of this study is to test an experimental drug combination of two medications currently approved by the Food and Drug Administration (FDA) for migraine headache or other pain. These are called rizatriptan given with acetaminophen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is at least 18 years of age
- •Subject has at least a 6 month history of migraine, with or without aura
- •Subject can distinguish between migraine attacks and other types of headaches
- •Subject of childbearing potential agrees to use adequate contraception
排除标准
- •Subject typically has fewer than 1 or greater than 6 migraine attacks per month
- •Subject typically has greater than 10 headache days per month
- •Subject has evidence of ischemic heart disease
- •Subject has uncontrolled high blood pressure
- •Subject has a history, within 1 year, or current evidence of drug or alcohol abuse
- •*This list is not all inclusive*
结局指标
主要结局
To compare the efficacy of rizatriptan co-administered with acetaminophen to placebo, acetaminophen and rizatriptan for the acute treatment of migraine, as measured by the percentage of patients with pain relief at 2 hours.
次要结局
- Functional disability
- Use of rescue medication
- Self-reported adverse experiences
- 24 hour sustained pain relief
- Pain relief at 30, 45,60,90 minutes and 4 hours post dose
- Pain freedom at 30,45,60,90 minutes and 2 and 4 hours post dose
- 24 sustained pain freedom
- Associated symptoms of phonophobia, photophobia, nausea and vomiting
研究者
研究点 (13)
Loading locations...
相似试验
撤回
2 期
Leidos-Enabled Adaptive Protocol for Clinical Trials (LEAP-CT) in Hospitalized Patients With COVID-19 (Addendum 1)2019 Novel Coronavirus Disease2019 Novel Coronavirus Infection2019-nCoV Disease2019-nCoV InfectionCOVID-19 PandemicCOVID-19 Virus DiseaseCOVID-19 Virus InfectionCovid19Coronavirus Disease 2019SARS-CoV-2 InfectionSARS-CoV-2 Acute Respiratory DiseaseCOVID-19NCT05085574Leidos Life Sciences
撤回
3 期
An Investigational Study to Assess Efficacy and Pattern of Use of SM-1 in Subjects With a History of Transient InsomniaTransient InsomniaNCT03338764Sequential Medicine Ltd
已完成
不适用
Optimizing Dose of Bupivacaine in Combined Spinal Epidurals To Reduce Side EffectsPregnancyNCT02159807St. Luke's-Roosevelt Hospital Center170
已完成
1 期
Safety and Efficacy Trial of DNA Vaccines to Treat Genital Herpes in AdultsGenital Herpes Simplex Type 2NCT02030301Vical165
终止
3 期
Lithium Versus Paroxetine in Patients With Major Depression Who Have a Family History of Bipolar Disorder or SuicideMajor Depressive DisorderNCT00400088Nova Scotia Health Authority2