National, Controlled, Randomized, Double-blind, Parallel Study to Investigate the Efficacy of 2 Capsules of Ibuprofen 400mg in Association With Caffeine 100mg in Fixed Dose Combination Compared to Two Capsules of Ibuprofen 400mg in the Treatment of Migraine
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Sanofi
- 主要终点
- Number of patients with reduction of at least 30mm in the visual scale (VAS) of pain
研究概览
简要总结
Primary Objective:
- To compare the treatment groups in the reduction of pain score by at least 30 mm on a visual pain scale (VAS) at 60 minutes after study medication intake, compared to the baseline score (obtained before the study medication intake).
Secondary Objectives:
-
To assess the proportion of patients with more than 50% pain relief, according to the VAS score at 45 minutes after study medication intake compared to baseline
-
Determine the following aspects in the timing of study medication intake:
-
Time to the first perception of pain relief
-
Time to onset of meaningful pain relief
-
Reduction of pain at 15, 30, 45, 60, 120 and 240 minutes after study medication intake, to be evaluated as the difference between the scores on VAS in each period and baseline
-
To assess the pain according to the five items of Headache Relief Rating - HRR (0: strong worsening 1: slight worsening 2: no change 3: slight improvement 4: strong improvement) at 15, 30, 45 and 60 minutes after study medication intake, according to the diaries completed by the patients
-
To check the proportion of the patients requiring the third tablet of study medication within 24 hours of starting the study treatment and when it occurred
-
To check the timing and frequency of rescue medication intake, as well as the proportion of patients who used these medications within 24 hours of starting the treatment
-
Safety assessment.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ibuprofen+caffeine
2 capsules
干预措施: IBUPROFEN + CAFFEINE (Drug)
Ibuprofen
2 capsules
干预措施: IBUPROFEN (Drug)
结局指标
主要结局
Number of patients with reduction of at least 30mm in the visual scale (VAS) of pain
时间窗: from baseline to 60 minutes
次要结局
- Number of patients with more than 50% of pain reduction(up to 45 minutes)
- Median time of the first perception of pain relief since study medication intake(4 hours)
- Median time to onset of significant pain relief compared to the time of study medication intake(4 hours)
- Headache Relief Rating score (HRR)(up to 60 mins)
- Mean of VAS difference between each time after medication intake and the baseline.(15, 30, 45, 60, 120 and 240 minutes post dose)
- Number of patients who used the third tablet of study medication(up to 24 hours)
- Number of patients requiring rescue medication(up to 24 hours)