NCT00567528终止不适用
Comparison of the Efficacy of Topical Ibuprofen to Oral Ibuprofen in Adolescent Athletes
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Efficacy of Topical Ibuprofen to Oral Ibuprofen measured by numeric pain rating, swelling at injury site, and change in sports activity.
研究概览
简要总结
This study was made to compare the efficacy of topical ibuprofen in gel form with oral ibuprofen in the treatment of sub-acute soft tissue injuries while comparing the tolerability of the delivery methods
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
- 12 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12-19yo
- •soft tissue injury or flare up of soft tissue injury within 10 days to 8 weeks
排除标准
- •Known hypersensitivity to aspirin or any NSAID,
- •allergy to eggs or egg products
- •history of asthma, renal disease, GI disease, active or suspected bleeding peptic ulcer (past or present), anemia, hypertension, other systemic disease significantly affecting liver or renal function
- •serious injury within six months
- •currently on anticoagulants
- •pregnant or lactating females
- •active arthritis in affected limb
- •open wounds, infected skin or fractures
- •opioid use within 7 days
- •severe psychological disorder
- •prior topical medication applied to the painful region/area of study
研究组 & 干预措施
1
Other
Active ibuprofen liposomal transdermal gel with placebo ibuprofen capsule
干预措施: ibuprofen (Drug)
2
Other
Placebo ibuprofen liposomal transdermal gel with active ibuprofen capsules
干预措施: ibuprofen (Drug)
结局指标
主要结局
Efficacy of Topical Ibuprofen to Oral Ibuprofen measured by numeric pain rating, swelling at injury site, and change in sports activity.
时间窗: 10 days to 8 weeks after initial injury or flare up
次要结局
- Compare the tolerability of the two delivery methods measured by side effects.(2 weeks after starting topical and oral ibuprofen)
研究者
Eloise Lemon
M.D.
Akron Children's Hospital
研究点 (1)
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