NCT01712451已完成2 期
Dose-ranging Study of the Safety and Efficacy of Fluticasone Propionate and Salmeterol Xinafoate in Healthy Patients With Abdominal Contour Defects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Safety
研究概览
简要总结
Dose ranging study
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 - 45 years of age inclusive
- •abdominal contour defect
- •BMI <25 kg/msq
- •Stable diet and exercise and body weight
排除标准
- •Prior treatment of abdominal contour defects (liposuction, abdominoplasty, etc)
- •Known hypersensitivity to study drugs
研究组 & 干预措施
LIPO-102, Low
Experimental
干预措施: salmeterol xinafoate, fluticasone propionate (Drug)
LIPO-102, Mid
Experimental
干预措施: salmeterol xinafoate, fluticasone propionate (Drug)
LIPO-102, High
Experimental
干预措施: salmeterol xinafoate, fluticasone propionate (Drug)
LIPO-102; Placebo
Experimental
干预措施: Placebo (Drug)
salmeterol xinafoate
Experimental
干预措施: salmeterol xinafoate (Drug)
结局指标
主要结局
Safety
时间窗: 8 weeks treatment
physical exam, vital signs, clinical assessment of injection, clinical laboratory tests, and adverse events
Change in abdominal circumference
时间窗: Baseline to 9 weeks
abdominal circumference
次要结局
- Change in Patient Reported Outcome Score(Baseline to 9 weeks)
- Change in global clinician scale score(Baseline to 9 weeks)
- Change in global patient scale score(Baseline to 9 weeks)
- Change in Photonumeric scale score(Baseline to 9 weeks)
研究者
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