A DOUBLE-BLIND, REPEAT-DOSE, PARALLEL GROUP, PILOT STUDY COMPARING THE EFFICACY AND SAFETY OF ORALLY ADMINISTERED IBUPROFEN AND PLACEBO IN DELAYED ONSET MUSCLE SORENESS
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Model Sensitivity
研究概览
简要总结
The study will assess the sensitivity of the Delayed Onset Muscle Soreness Model by comparing the safety and efficacy of oral ibuprofen to placebo over 24 hours.
详细描述
This is a double-blind, randomized, placebo controlled, parallel group, pilot safety and efficacy study. Healthy male or female subjects who have a history of occasional muscle soreness and are not currently exercising will be asked to volunteer for the study. All subjects will complete an informed consent process prior to study procedures.
The study duration is anticipated to be approximately 4 months. Each subject may be in the study for up to 45 days including screening, run-in, inpatient and outpatient dosing and assessments, follow-up visit and follow-up telephone contact.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ibuprofen
Subjects will receive a total of 4 doses of oral ibuprofen 400 mg over a 24 hour period.
干预措施: Ibuprofen 400 mg (Drug)
Placebo
Subjects will receive a total of 4 doses of oral placebo over a 24 hour period.
干预措施: Placebo (Other)
结局指标
主要结局
Model Sensitivity
时间窗: 24 hours
Assess whether ibuprofen provides more relief than placebo in the DOMS model.
次要结局
未报告次要终点
研究者
Derek Muse
Principal Investigator
Jean Brown Research