A Study to Assess the Efficacy of Paracetamol Taken in Combination With Caffeine for the Treatment of Episodic Tension Type Headache
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 66
- 试验地点
- 7
- 主要终点
- Time to First Perceptible Headache Relief
研究概览
简要总结
This study will compare a fast-absorbing paracetamol plus caffeine formula with placebo and an over-the-counter dose of paracetamol and ibuprofen to treat episodic tension headache.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Diagnosis of episodic tension-type headache consistent with all of the following:
- •number of days with the condition is historically greater than or equal to two per month
- •onset of condition was greater than or equal to 12 months from Visit 1
- •age of onset was < 50 years
- •severity of headaches is historically at least moderate
- •duration of headaches is historically greater than or equal to four hours, if untreated
- •number of headache episodes was greater than or equal to 4 and less than or equal to 10 during each of the three months immediately prior to Visit 1
- •treatment of headache episodes with OTC analgesics has historically provided pain relief in less than or equal to 2 hours
排除标准
- •Subject has chronic tension type headache, which is defined as headache on more than 15 days per month for 3 months.
- •If a migraine sufferer,subject averages more than one episode per month, is incapable of differentiating between tension-type headaches and migraine headaches, and/or requires regular or prophylactic use of migraine medications
研究组 & 干预措施
Arm 1
Placebo
干预措施: Placebo (Drug)
Arm 2
paracetamol marketed forumulation
干预措施: Paracetamol marketed formulation (Drug)
Arm 3
ibuprofen marketed formulation
干预措施: ibuprofen marketed formulation (Drug)
Arm 4
experimental paracetamol + caffeine formulation
干预措施: Experimental paracetamol + caffeine formulation (Drug)
结局指标
主要结局
Time to First Perceptible Headache Relief
时间窗: Baseline to 6 hours
Time to first perceptible pain relief, calculated as time when partcipant selected 'a little' pain relief in the electronic pad minus the time of treatment. If this time was not available in the electronic pad then the earliest time corresponding to a pain relief score 1 or greater was recorded as time to 'a little' pain relief.
次要结局
- Headache Relief Scores(Baseline to 4 hours)
- Total Pain Relief (TOTPAR)(Baseline to 4 hours)
- Sum of Pain Intensity Difference (SPID)(Baseline to 4 hours)
- Sum of TOTPAR and SPID (SPRID)(Baseline to 4 hours)
- Time to Rescue Medication(Baseline to 6 hours post dose)
- Number of Participants With Complete Headache Relief(Baseline to 2 hours)
- Headache Severity(Baseline to 4 hours)
- Patients Global Assessment in Response to Treatment(Baseline to 8 weeks)