NCT01035346终止3 期
Evaluation Of The Antipyretic Efficacy Of Ibuprofen Sodium Tablets In Subjects With An Uncomplicated Acute Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6)
研究概览
简要总结
This single-dose trial will evaluate the efficacy of a novel ibuprofen formulation compared to placebo in patients with a fever due to an uncomplicated acute infection.
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
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with a fever secondary to an uncomplicated acute viral or bacterial infection.
- •Oral temperature measurement from 100 to 104 degrees Fahrenheit.
- •Onset of fever 3 days or less.
- •Otherwise good health.
排除标准
- •Fever secondary to a chronic underlying medical condition or serious infection.
- •Currently taking antibiotics or antivirals.
- •Currently taking any medication which may interfere with the assessment of fever.
- •Pregnancy or breast-feeding.
- •Any serious medical or psychiatric disorder.
研究组 & 干预措施
A
Experimental
干预措施: Ibuprofen (Drug)
B
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6)
时间窗: 0 to 6 hours
STEMPD 0-6 was defined as time-weighted sum of temperature differences over 6 hours, weighted by the time elapsed between each 2 consecutive time points. Temperature difference was defined as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.
次要结局
- Time-weighted Sum of The Temperature Differences From Baseline Through Hour 4 and Hour 8 (STEMPD 0-4 and STEMPD 0-8)(0 to 4, 0 to 8 hours)
- Change From Baseline in Temperature at Hours 0.25, 0.5, 1, 2, 4, 6 and 8(Baseline, 0.25, 0.5, 1, 2, 4, 6, 8 hours)
- Time to Treatment Failure(0 to 8 hours)
- Cumulative Percentage of Participants With Treatment Failure(0.25, 0.5, 1, 2, 4, 6, 8 hours)
- Global Assessment of Study Medication as an Antipyretic(8 hours)
- Rating of Study Medication Relative to Usual Medication(8 hours)
研究者
研究点 (1)
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