NCT01655082已完成2 期
Nicotine Patch Safety Study
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
- 160
- 主要终点
- Safety
研究概览
简要总结
The purpose of this study is to evaluate the safety profile of a repeated application of a new transdermal patch compared to a reference product during 3 weeks, in a large population.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged more than 18 years
- •Regular smoker motivated to stop tobacco consumption
- •Current smoker of > or = 20 cigarettes/day and < or = 25 cigarettes/day or Fagerström score > or = 5 (for smokers between 10 to 20 cigarettes/day)
排除标准
- •Any visible skin disorder, abnormal skin pigmentation or other dermatologic disease which, in the opinion of the investigator would interfere with the assessment of the different parameters
- •Current or past serious chronic cardiovascular, renal, hepatic, gastrointestinal (including duodenal or gastric ulcer), endocrine, hematological, neuropsychiatric, immunosuppressive condition or allergic disease, myopathies, epileptic seizures, bleeding tendency, cancer
- •History of angina pectoris, myocardial infarction or stroke in the previous 3 months, coronary artery vasospasm, cardiac arrhythmia, acute stroke
- •Clinically relevant abnormal findings on the physical examination (e.g large scars on the application zone)
研究组 & 干预措施
V0116
Experimental
One patch per day (during 24 hours) for 21 days
干预措施: V0116 transdermal patch (Drug)
Reference
Active Comparator
One patch per day (during 24 hours) for 21 days
干预措施: Nicotine transdermal patch (Drug)
结局指标
主要结局
Safety
时间窗: up to Day 22
Evaluation of local safety (number of subjects with skin irritation / number of subjects by score of adhesiveness) and general safety (number of subjects with emergent adverse events or changes from baseline to end of study in vital signs, electrocardiogram and clinical laboratory parameters).
次要结局
- Sensory profile(Day 22)
- Global assessment by the patient(Day 22)
- Subject behaviours(up to Day 22)
研究者
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