Clinical Trial Phase III, Prospective, Randomized, Double-blind, Multicenter, National, Comparative Between Oxybutynin Chloride With Placebo to Evaluate the Efficacy and Safety for Systemic Treatment of Primary Hyperhidrosis.
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Oxybutynin Chloride efficacy
研究概览
简要总结
Treatment of primary hyperhidrosis through a comparative study between oxybutynin hydrochloride and placebo.
Hydrochloride may decrease the symptoms of hyperhidrosis improving the subject's quality of life.
详细描述
Clinical Trial phase III, randomized, national, prospective, double-blind, multicenter, comparative between oxybutynin hydrochloride and placebo, to be held in participants aged over 18 years to evaluate the therapeutic efficacy and safety of oxybutynin chloride to systemic treatment of primary hyperhidrosis.
Primary hyperhidrosis is a relatively common disorder, affecting approximately 3% of the population. It affects both sexes similarly and in all age groups, varying only the starting age of symptoms according to the most affected part of the body:
childhood - plantar and palmar hyperhidrosis adolescence - axillary hyperhidrosis adult - craniofacial hyperhidrosis
There is a family history associated with between 12.5% and 56.5% of the participants, according to epidemiological studies.
Initially the subjects will be evaluated on the inclusion and exclusion criteria through screening and safety tests such as blood tests , ECG and tonometry, to confirm enrollment.
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
- Double (Participant, Investigator)
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
- •Understanding, agreement and consent form signed;
- •Literate;
- •Confirmed diagnosis for primary hyperhidrosis;
- •Screening tests at normal standards;
- •Absence of pregnancy by Beta-human chorionic gonadotropin test;
排除标准
- •Secondary Hyperhidrosis;
- •Myasthenia gravis;
- •Lactation;
- •Hypersensitivity to oxybutynin;
- •Use more than 500mg of caffeine;
- •Alcoholism;
- •Use of illicit drug;
- •Changes in ECG (echocardiogram) or tonometry;
- •Any clinical condition that the investigator considers clinically significant.
研究组 & 干预措施
Oxybutynin Chloride
- Tablet
- Dose 5,0 or 10 mg/ day
干预措施: Oxybutynin (Drug)
Placebo
- Tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Oxybutynin Chloride efficacy
时间窗: 6 weeks
Evaluation of the therapeutic efficacy by Oxybutynin Hydrochloride in the treatment of primary hyperhidrosis.
次要结局
- Perception of improvement(During treatment until week 8)
- Evaluate therapeutic safety(During treatment until week 8)
- Quality of life(During treatment until week 8)
- Time of subject response(End of 8 weeks)
- Duration of response(End of 8 weeks)
- Evaluation between quality of life and groups(End of 8 weeks)