Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Episodic Tension-Type Headache
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 200
- 主要终点
- Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet
研究概览
简要总结
This study will compare the ability of a single-dose of a novel ibuprofen formulation to relieve pain compared to placebo and standard ibuprofen in the treatment of episodic tension-type headache.
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
- Quadruple (Participant, Care Provider, 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
- •Males and females at least 18 years to 65 years of age
- •A diagnosis of an episodic tension-type headache, as defined by the International Headache Society
- •A history of episodic tension-type headache with the following characteristics: 4 headache episodes per month for the last 6 months of moderately severe intensity; headache generally lasts more than 3 hours if left untreated; adequate headache relief is generally obtained with over-the-counter (OTC) doses of OTC analgesics
排除标准
- •Pregnancy or breast-feeding
- •Alcohol or substance abuse
- •Any serious medical or psychiatric disorder
- •History of stomach ulcers, stomach bleed, or other bleeding disorders
研究组 & 干预措施
Treatment A
干预措施: Novel Ibuprofen (Drug)
Treatment B
干预措施: Standard Ibuprofen (Drug)
Treatment C
干预措施: Placebo (Drug)
结局指标
主要结局
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet
时间窗: 0 to 3 hours
SPRID:time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 3 hours. SPRID score range:-3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of pain intensity differences (PID) and pain relief rating(PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). PRR:assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).
Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet
时间窗: 0 to 3 hours
Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated "meaningful relief" at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.
次要结局
- Time to Onset of Meaningful Relief: Remaining Comparisons(0 to 3 hours)
- Time to Confirmed First Perceptible Relief(0 to 3 hours)
- Pain Relief Rating (PRR)(1, 2, 3 hours)
- Pain Intensity Difference (PID)(1, 2, 3 hours)
- Sum of Pain Relief Rating and Pain Intensity Difference (PRID)(1, 2, 3 hours)
- Time-weighted Sum of Pain Intensity Difference (SPID)(0 to 2, 0 to 3 hours)
- Time-weighted Sum of Pain Relief Rating (TOTPAR)(0 to 2, 0 to 3 hours)
- Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)(0 to 2, 0 to 3 hours)
- Cumulative Percentage of Participants With Meaningful Relief(0.5, 1, 2, 3 hours)
- Cumulative Percentage of Participants With Confirmed First Perceptible Relief(0.5, 1, 2, 3 hours)
- Time to Treatment Failure(0 to 3 hours)
- Cumulative Percentage of Participants With Treatment Failure(0 to 3 hours)
- Cumulative Percentage of Participants With Complete Relief(1, 2, 3 hours)