EUCTR2007-007055-13-DE进行中（未招募）不适用
DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED PROSPECTIVE MULTI-CENTRE PHASE III TRIAL TO ASSESS THE EFFICACY AND SAFETY OF METHANTHELINIUM BROMIDE (VAGANTIN®) IN THE TREATMENT OF FOCAL PALMAR-AXILLARY HYPERHIDROSIS
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 336
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •male and female patients, aged 18-65 years
- •Caucasian origin
- •focal hyperhidrosis (axillary or focal palmar-axillary, > 50 mg/5min both axillae and > 30 mg/5min both palms – palmar hyperhidrosis will only be assessed, if the condition >30 mg/5min is fulfilled)
- •duration of clinically manifested hyperhidrosis for at least 1 year
- •failure of at least one topical treatment course
- •written informed consent given by patient after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug
- •female subjects of childbearing potential willing to use contraception during the study period (i.e. abstinence, oral contraception, intrauterine device, diaphragm, condom, spermicide, implant contraception, systemic contraception) or have secondary infertility or whose partner had a vasectomy, or female subjects of non childbearing potential (i.e. had hysterectomy, bilateral ovariectomy, tube ligation) or are post-menopausal defined as absence of menstrual bleeding for 1 year, or 6 month if laboratory confirmation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •secondary axillary hyperhidrosis
- •hidrosadenitis axillaris/inguinalis
- •prior surgery of perspiratory glands or endoscopic thoracic sympathectomy
- •iontophoresis 6 months or botulinum toxin treatment 12 months prior
- •other concomitant medication which would interfere with trial medication as
- •antiperspirants (e.g. topical application of aluminium chloride 15%-30% dilution) diaphoretics), anticholinergics (bornaprine hydrochloride), antihistaminics
- •beta-sympathomimetics, amantadine , tricyclic antidepressants, chinidine, disopyramide; last intake at least 8 weeks respectively 10 half-lives of the respective drugs
- •concomitant procedures which would interfere with trial medication as iontophoresis
- •mechanical stenosis in the gastro-intestinal tract, severe chronic, inflammatory intestinal disease or toxic megacolon
- •urinary retention in the case of prostate adenoma or other subvesical obstruction
- •narrow-angle glaucoma
- •tachycardia or cardiac arrhythmia
- •myasthenia gravis
- •renal insufficiency or pre-existing severe liver disease
- •spicy meals before gravimetric measurements
- •patients with hereditary fructose or galactose intolerance
- •patients with hereditary glucose galactose malabsorption (GGM)
- •patients with congenital lactase or saccharase-isomaltase defect
- •known contraindication for study medication (or any of the excipients contained in the product, i.e. sunset yellow S, lactose, sucrose)
- •unreliability and/ or lack of cooperation, evidence of non-compliance
- •current or previous participation in another clinical trial within prior 12 weeks
- •pregnancy or lactation in female patients
- •signs of clinically relevant illness or mental illness
- •history of or current alcohol or drug abuse
- •other objections which avoid the participation in the study in the opinion of the investigator
- •persons committed officially or legally to an institution
- •legal capacity and/or other circumstances rendering the patient able to understand the nature, scope and possible consequences of the study
研究者
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