ACTRN12615000873527进行中（未招募）2 期
A Phase 2a Study Evaluating the Safety and Efficacy of THVD-102, a combination of Oxybutynin and Pilocarpine, in Subjects with Primary Focal Hyperhidrosis.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1.Men or women
- •2.Able to provide written/signed informed consent
- •3.Age 18 to 70 (inclusive) years old at time of informed consent
- •4.Confirmed diagnosis of primary focal hyperhidrosis with axillary or palmar hyperhidrosis alone or in combination with another location (Hornberger)
- •Focal, visible, excessive sweating of at least six months duration without apparent cause with at least two of the following characteristics:
- •1.Bilateral and relatively symmetric
- •2.Impairs daily activities
- •3.Frequency of at least one episode per week
- •4.Age of onset less than 25 years
- •5.Positive family history
- •6.Cessation of focal sweating during sleep
- •5.Adequate renal and hepatic function:
- •a.Serum creatinine and estimated creatinine clearance < 1.5 x upper limit of normal range, and
- •b.ALT or AST <1.5 x upper limit of normal range
- •6.Negative serum pregnancy test for women of childbearing potential (WOCBP) within the 7 days prior to the first study treatment and a negative urine pregnancy test within the 1 day prior to the start of each subsequent treatment period
- •7.Women of childbearing potential (WOCBP) who are subjects and male subjects who are sexually active with WOCBP must agree to use 2 methods of highly effective contraception during the clinical trial
- •8.Willingness and ability to comply with the study protocol for the duration of the clinical trial
- •9.HDSS score of 3 or 4 at oxybutynin Run in Period Day -1 or Day -1 of Treatment Period 1 if completed the oxybutynin Run-In as a part of Study THVD 402-201.
- •10.A rating of wet hands” or dripping hands” on the Hyperhidrosis Visual Quantification Scale palmar for subjects with palmar hyperhidrosis or wet” or dripping” on the Hyperhidrosis Visual Quantification Scale axillary at Oxybutynin Run in Period Day -1 or Day -1 of Treatment Period 1 if completed the Oxybutynin Run-In as a part of Study THVD 402-201.
- •11.Dry Mouth or Dry Throat Visual Analog Scale (DM/TVAS) score of greater than or equal to 25 mm at Oxybutynin Run in Period Day 21. Subjects who participated in Study THVD 402 201 who have a documented DMVAS of at least 25mm following the Oxybutynin Run-In period do not need to complete the open label oxybutynin run in period in this trial; these subjects can begin this trial with Treatment Period 1.
排除标准
- •1.Women who are pregnant or breast feeding
- •2.QTc interval > 450 msec (males) > 475 msec (females)
- •3.Contraindication to oxybutynin and/or pilocarpine
- •a.Urinary retention or significant bladder outflow obstruction
- •b.Gastric retention, gastrointestinal obstructive disorder (e.g., pyloric stenosis), or decreased gastric motility
- •c.Narrow angle glaucoma or acute iritis
- •d.Myasthenia gravis
- •e.Asthma, chronic bronchitis or COPD requiring pharmacological therapy
- •f.Significant cardiovascular disease, including uncontrolled hypertension
- •g.Known or suspected cholelithiasis or biliary tract disease
- •h.Known or suspected renal colic or nephrolithiasis
- •i.Previous hypersensitivity to pilocarpine or oxybutynin
- •j.Any other condition in which administration of oxybutynin or pilocarpine may pose a significant risk to the patient
- •4.Botox Registered Trademark (onabotulinumtoxinA) treatment during the 8 months prior to screening or iontophoresis during the 2 months prior to screening
- •5.History of local surgical excision or laser removal (e.g. Miradry) of eccrine or apocrine glands of the axillae
- •6.Any reason, in the opinion of the investigator that a subject would not be a reliable subject and provide accurate data
研究者
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