Trial document




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  DRKS00000474

Trial Description

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Title

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

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Evaluation of the efficacy and safety of Vagantin® in comparison to placebo in the treatment of excessive sweating under armpits and on hands

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Brief Summary in Scientific Language

Evaluation of the efficacy and safety of Vagantin® (methanthelinium bromide) in comparison to placebo in the treatment of axillary-palmar hyperhidrosis

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Organizational Data

  •   DRKS00000474
  •   2010/07/05
  •   [---]*
  •   no
  •   Approved
  •   ZS EK 10 550/08, Ethik-Kommission des Landes Berlin
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Secondary IDs

  •   U1111-1115-8816 
  •   2007-007055-13 
  •   4034789 
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Health Condition or Problem studied

  •   R61 -  Hyperhidrosis
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Interventions/Observational Groups

  •   Vagantin 150 mg / day
  •   Placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Double or multiple blind
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  •   Placebo
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

axillary sweat gravimetry (mean of both axillae) on day 28 +/- 1

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Secondary Outcome

• axillary sweat gravimetry on day 14 +/- 1
• palmar sweat gravimetry on days 14 +/- 1 and 28 +/- 1
• hyperhidrosis disease severity scale (HDSS) on days 14 +/- 1 and 28 +/- 1
• dermatology life quality index (DLQI) on days 14 +/- 1 and 28 +/- 1

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2010/06/13
  •   336
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

• male and female patients, aged 18-65 years
• Caucasian origin
• focal hyperhidrosis (axillary or focal palmar-axillary, > 50 mg/5min both axillae and > 50 mg/5min both palms – palmar hyperhidrosis will only be assessed, if the condition >50 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 if laboratory confirmation of hormonal status

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Exclusion Criteria

• 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, ß-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, liposuction-curettage, local excision, endoscopic thoracic sympathectomy
• 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 incapacity and/or other circumstances rendering the patient able to understand the nature, scope and possible consequences of the study

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Addresses

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    • RIEMSER Arzneimittel AG
    • Mr.  Dr. med.  Berno  Müller 
    • An der Wiek 7
    • 17493  Greifswald - Insel Riems
    • Germany
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    • Division of Evidence Based Medicine dEBM Klinik für Dermatologie Charité - Universitätsmedizin Berlin
    • Mr.  Prof. Dr. med.  Berthold  Rzany 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Division of Evidence Based Medicine dEBM Klinik für Dermatologie Charité - Universitätsmedizin Berlin
    • Mr.  Prof. Dr. med.  Berthold  Rzany 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • RIEMSER Arzneimittel AG
    • An der Wiek 7
    • 17493  Greifswald - Insel Riems
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.