E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of patients with axillary and palmar hyperhidrosis |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluation of the efficacy and safety of Vagantin® (methanthelinium bromide) in comparison to placebo in the treatment of axillary-palmar hyperhidrosis. Primary Target: axillary sweat gravimetry on day 28 +/- 1 |
|
E.2.2 | Secondary objectives of the trial |
• 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
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Specific: • 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 General: • 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 |
|
E.4 | Principal exclusion criteria |
Specific: • 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
General: • 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
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
axillary sweat gravimetry on day 28 +/- 1 day |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |