NCT01814189已完成3 期
Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment: a Randomized, Double Blind Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Complete headache relief
研究概览
简要总结
The purpose of this study is to show the efficacy of promethazine in management of patients with moderate to severe migraine
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who aged 18 to 65 years with a clinical history of migraine with or without aura (International Headache Society categories 1.1 or 1.2) for at least 1 year
- •Subjects who have mean frequency of 2-8 migraine attacks per month.
排除标准
- •Complex form of migraine, medication overuse headache, history of chronic tension-type headache, ophthalmoplegic, basilar and hemiplegic migraine
- •Uncontrolled hypertension (diastolic blood pressure >95 mm Hg or systolic blood pressure >160 mm Hg)
- •History or clinical evidence of cerebrovascular or cardiovascular disorder
- •Renal impairment or dialysis dependence
- •Serious illness (physical or psychiatric disorders)
- •Drugs and alcohol abuse
- •Pregnancy and breastfeeding
- •Allergy or hypersensitivity to promethazine or triptans
- •Concurrent use of ergotamine-containing drugs, monoamine oxidize inhibitors, antidepressant, lithium
研究组 & 干预措施
sumatriptan+promethazine (SPr)
Active Comparator
The SPr group denote patients receiving oral sumatriptan (50 mg) plus oral promethazine (50 mg).
干预措施: Sumatriptan+Promethazine (SPr) (Drug)
Sumatriptan+placebo (SP)
Placebo Comparator
The SP group denote patients receiving oral sumatriptan (50 mg) plus tablet of placebo matched to promethazine.
干预措施: Sumatriptan+Promethazine (SPr) (Drug)
结局指标
主要结局
Complete headache relief
时间窗: At 2 hours after first dose
The primary endpoint variable was the proportions of patients reporting complete headache relief 2 hours after dosing.
次要结局
- Occurrence of adverse events.(At 4 hours after first dose.)
- Complete headache relief(At 0.5 hour, 1 hour, and 4 hours after first dose)
- Headache improvement.(At 0.5 hour, 1 hour, 2 hours, 4 hours after first dose.)
- Using the second dose of study medications.(At 2-48 hours after first dose.)
- Using rescue medication between 2 and 48 hours postdose(At 4-48 hours after second dose.)
- Rate of headache recurrence(At 2-48 hours after first dose.)
研究者
Shadi Asadollahi
Research Assistant of Neurology
Shahid Beheshti University of Medical Sciences
研究点 (1)
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