NCT01464983已完成4 期
A Multicentre Randomised Parallel-groups Double-blind Double-dummy Single-dose Study to Compare Acetylsalicylic Acid 500 mg and 1,000 mg With Ibuprofen 200 mg and 400 mg and Placebo for Tolerability and Efficacy in the Treatment of Episodic Tension-type Headache
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,115
- 主要终点
- Percentage of subjects with total or meaningful headache relief at 2 hours after intake of study medication
研究概览
简要总结
The purpose of this study is to determine the efficacy and tolerability of 500 mg and 1000 mg Aspirin® (study medication) by comparing it to placebo (the control group without active substance) or 200 mg or 400 mg Ibuprofen (study medication) in treating the symptoms of episodic tension-type headache. The study is designed to develop a treatment method against episodic tension-type headache which will have more advantages for patients than the methods that are currently available.
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
- •Ambulatory male or female, 18 to 65 years of age
- •Normal blood pressure
- •Patients suffering from episodic tension-type headache
- •Headache lasting from 30 minutes to 7 days
- •Headache had at least two of the following characteristics:
- •Bilateral location. Pressing/tightening (non-pulsating). Mild or moderate intensity. Not aggravated by routine physical activity such as walking or climbing stairs.
- •Both of the following: No nausea or vomiting. No more than one of photophobia or phonophobia.
排除标准
- •Other headaches, including migraine, that required medical treatment
- •Hypersensitivity to acetylsalicylic acid, salicylates, ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs)
- •Serious physical illness especially uncontrolled disorders of kidney, liver, lung, heart or brain function, neurological disorders or severe chronic or terminal disease
- •Mental illness, including depression
- •Needed or were using or likely to need or use any of the prohibited concomitant medications: antidepressants, oxicams
- •Pregnant or lactating women, or sexually active women of child-bearing potential unless using effective contraception
- •Participating in any other clinical study or had done within the previous 4 weeks
- •Had been previously enrolled in this study
研究组 & 干预措施
Arm 1
Active Comparator
干预措施: Acetylsalicylic acid (Aspirin, BAYE4465) (Drug)
Arm 2
Experimental
干预措施: Acetylsalicylic acid (Aspirin, BAYE4465) (Drug)
Arm 3
Active Comparator
干预措施: Ibuprofen (Drug)
Arm 4
Active Comparator
干预措施: Ibuprofen (Drug)
Arm 5
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of subjects with total or meaningful headache relief at 2 hours after intake of study medication
时间窗: 2 hours post dose
次要结局
- Measuring the functional ability on conducting everydays activity on a 4 point categorical scale(2 and 24 hours post dose)
- Global assessment of pain therapy(24 hours post dose)
- Safety - assessment of adverse events(Up to 10 weeks after screening)
- Headache pain relief measured serially on a categorical scale(Until 4 hours post dose)
研究者
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