A Study to Assess Efficacy Over Placebo and Speed of Onset of Pain Relief of New Paracetamol and Caffeine Tablets as Compared to Ibuprofen in Episodic Tension Type Headache
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 365
- 试验地点
- 1
- 主要终点
- Sum of Pain Intensity Difference (SPID) of Treatment and Placebo at 4 Hours
研究概览
简要总结
The purpose of this multi-center study is to assess the efficacy of headache relief of new paracetamol/caffeine formulation compared to placebo and ibuprofen in episodic tension-type headache (ETTH).
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 (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
- 是
入选标准
- •Participants in good general health, and with diagnosis of ETTH with following conditions:
- •number of days with the condition is historically greater than or equal to two per month;
- •severity of headaches is historically at least moderate;
- •duration of headaches is historically more than or equal to 4 hours, if untreated.
排除标准
- •Participant with known or suspected hypersensitivity, allergy, intolerance or contraindication to the use of any of the study medications
- •Participant has chronic tension type headache, psychiatric disease or a significant cognitive disorder, or any chronic pain disorder.
- •Participant currently taking or has taken medications or herbal supplements within the three months that are likely to interfere with the validity of subject-rated assessments.
研究组 & 干预措施
Paracetamol/ Caffeine Caplets
Two caplets of paracetamol/caffeine combination plus 2 placebo caplets to be administered
干预措施: Paracetamol and Caffeine (Drug)
Ibuprofen Caplets
Two ibuprofen caplets plus two placebo caplets to be administered
干预措施: Ibuprofen (Drug)
Placebo Caplets
Four placebo caplets to be administered
干预措施: Placebo (Other)
结局指标
主要结局
Sum of Pain Intensity Difference (SPID) of Treatment and Placebo at 4 Hours
时间窗: Up to 4 hours post dose
SPID was calculated as the weighted sum of Pain (Headache) intensity differences at 4 hours post dose. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120, 120-180, 180-240 minutes. The range of SPID at 4 hours post dose was from -12 to 4". PID was calculated as difference of pain intensity (PI) at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache).
次要结局
- Time to Meaningful Headache Relief(Baseline up to 4 hours)
- Total Pain Relief (TOTPAR)(From (Baseline) 0 to 1, from 0 to 2, from 0 to 3 and from 0 to 4 hour post dose)
- Number of Participants With Perceptible Pain Relief(Baseline up to 4 hours)
- Time to Perceptible Headache Relief(Baseline up to 4 hours)
- Number of Participants With Meaningful Pain Relief(Baseline up to 4 hours)
- Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 Hours(From (Baseline) 0 to 1 hour, 0 to 2 hours, and 0 to 3 hours post dose)
- Area Under the Time-Response Curve for Change in Headache Intensity and Headache Relief (SPRID)(From (Baseline) 0 to 1 hour, 0 to 2 hours, 0 to 3 hours and 0 to 4 hours post dose)
- Global Evaluation of Response to Treatment(4 hours)
- Rate of Rescue Medication(4 hours)
- Change From Baseline in Headache Pain Intensity(At 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 min.)
- Headache Relief(At 10 min. 15 min., 20 min., 25 min., 30 min., 40 min., 50 min., 60 min., 90 min., 120 min., 180 min., 240 min.,)
- Number of Pain Free Participants(1 hour and 2 hour post dose)
- Time to the Use of Rescue Medication.(Up to 4 hours)