NCT02113566已完成4 期
A Double-Blind, Repeat-Dose, Parallel Group Study Comparing the Efficacy and Safety of Orally Administered Ibuprofen and Placebo in Delayed Onset Muscle Soreness.
Jean Brown Research1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- SPID (Sum Pain Intensity Difference)
研究概览
简要总结
The hypotheses to be tested are: Efficacy: Ibuprofen will be more effective than the Placebo in relieving muscle pain/soreness over 48 hour post-dosing with study medication. Safety: There will be no or minimal increased incidence of adverse events (AEs) with Ibuprofen versus and both will be well tolerated.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •are male or female, 18-55 years of age
- •are a sexually active female of childbearing potential willing to use a medically acceptable form of birth control throughout the study and for 30 days following the end of study participation
- •have a history of experiencing muscle soreness after moderately strenuous exercise
- •are in good general health, with a BMI less than or equal to 30, and able to perform the exercise regimen
- •are able to read, comprehend, and sign the informed consent form
- •develop muscle pain/soreness within 24-48 hours of the end of the exercise regimen and have a baseline muscle pain/soreness with movement of greater than or equal to 5 on the NRS (numerical rating scale) and at least "moderate" on the categorical scale
排除标准
- •regularly works out or exercises the upper extremities with weights or gym equipment during the past 6 months
- •works in an occupation that requires regular heavy lifting or involvement of the upper extremities (eg: mover, construction workers)
- •allergy or intolerance to any non-steroidal anti-inflammatory drug (NSAID), aspirin or acetaminophen
- •the presence of any medical condition (eg: history of bleeding ulcers or current peptic ulcer disease) that would preclude the subject from safely participating in the study'
- •any form of arthritis that requires prescription or over-the-counter (OTC)treatment pregnant or lactating female
- •current habituation or history of chronic use of analgesic or drugs or severe chronic pain problems that do not respond to OTC medication and/or requires a prescription analgesic
- •currently on chronic NSAID therapy for any reason
- •current or recent history of drug or alcohol abuse
- •has taken an analgesic medication within 5 half lives of performing the exercise regimen during the run-in period or completing the baseline assessment
- •has donated blood within the past 30 days
- •is unable to swallow whole or large tablets or capsules
- •is unable/unwilling to remain at the study center for the 6 hour inpatient observation period.
- •participation in an investigational study within the past 30 days of screening
- •prior participation in this trial
- •site employee or close relative of a site employee directly involved in the conduct or the study or is an employee or close relative of the study doctor.
研究组 & 干预措施
Placebo
Placebo Comparator
2 capsules identical to comparator, 3 times daily on Day 1 and Day 2. On Day 3 only one dose will be taken. The intervention is Acetaminophen 1000mg.
干预措施: Acetaminophen 1000mg (Drug)
Ibuprofen
Active Comparator
2oomg capsules (400 mg per dose), 3 times daily on Day 1 and Day 2. On Day 3 only one dose will be taken. The intervention is Acetaminophen 1000mg.
干预措施: Acetaminophen 1000mg (Drug)
结局指标
主要结局
SPID (Sum Pain Intensity Difference)
时间窗: 0-48 hours
The primary efficacy parameter is muscle pain/soreness with movement at 48 hours (SPID 0-48)
次要结局
- spontaneous muscle pain/soreness(0-48 hours)
- Muscle stiffness with movement(0-48 hours)
- Overall evaluation measures(0-48 hours)
研究者
Derek Muse
Derek Muse, MD
Jean Brown Research
研究点 (1)
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