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临床试验/NCT01118429
NCT01118429已完成不适用

Use of Oxybutynin to Treat Axillary Hyperhidrosis

Grupo de Cirurgia Vascular1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Effectiveness of treatment using a clinical questionnaire

研究概览

简要总结

The objective of this study was to evaluate the effectiveness and patient satisfaction with the use of oxybutynin at low doses for treating axillary hyperhidrosis in a large series of patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
14 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • patients with axillary hyperhidrosis

排除标准

  • glaucoma and micturition disorders, pregnancy

研究组 & 干预措施

Oxybutynin

Experimental

Oxybutynin was prescribed for 12 weeks, in progressively increasing doses throughout treatment. At their first visit, the patients were given 2.5 mg of oxybutynin into be taken once a day in the evening, were instructed to increase the dose to 2.5 mg twice a day from the eighth to the 42nd day, and to contact the doctor if they experienced any side effect. After this period they were seen in a second visit, and the dose was increased to 5 mg twice a day from the 43rd to the end of the 84thday, to when a third visit was scheduled.

干预措施: Oxybutynin (Drug)

Placebo

Placebo Comparator

Oxybutyinine was prescribed for 12 weeks, in progressively increasing doses throughout treatment. At their first visit, the patients were given 2.5 mg of oxybutyn into be taken once a day in the evening, were instructed to increase the dose to 2.5 mg twice a day from the eighth to the 42nd day, and to contact the doctor if they experienced any side effect. After this period they were seen in a second visit, and the dose was increased to 5 mg twice a day from the 43rd to the end of the 84thday, to when a third visit was scheduled.

干预措施: Placebo (Drug)

结局指标

主要结局

Effectiveness of treatment using a clinical questionnaire

时间窗: After 12 weeks of treatment

These evaluations were used to assess (1) the patients' clinical improvement in axillary hyperhidrosis, using a clinical questionnaire: de Campos JR, Kauffman P, Werebe Ede C, Andrade Filho LO, Kusniek S, Wolosker N, Jatene FB.Quality of life, before and after thoracic sympathectomy: report on 378 operated patients.Ann Thorac Surg. 2003 Sep;76(3):886-91

Effectiveness of treatment by a clinical questionnaire

时间窗: 6 weeks of treatment

These evaluations were used to assess (1) the patients' clinical improvement in axillary hyperhidrosis, using a clinical questionnaire, published at 2003: de Campos JR, Kauffman P, Werebe Ede C, Andrade Filho LO, Kusniek S, Wolosker N, Jatene FB.Quality of life, before and after thoracic sympathectomy: report on 378 operated patients.Ann Thorac Surg. 2003 Sep;76(3):886-91

次要结局

  • Treatment of hyperhidrosis at other sites(6 weeks)

研究者

发起方
Grupo de Cirurgia Vascular
申办方类型
Other

研究点 (1)

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