Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis

Cristalia

Status and phase: Withdrawn; Phase 3

Conditions: Hyperhidrosis

Treatments: Drug: Placebo; Drug: Oxybutynin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02099695

CRT069

Details and patient eligibility

About

Treatment of primary hyperhidrosis through a comparative study between oxybutynin hydrochloride and placebo.

Hydrochloride may decrease the symptoms of hyperhidrosis improving the subject's quality of life.

Full description

Clinical Trial phase III, randomized, national, prospective, double-blind, multicenter, comparative between oxybutynin hydrochloride and placebo, to be held in participants aged over 18 years to evaluate the therapeutic efficacy and safety of oxybutynin chloride to systemic treatment of primary hyperhidrosis.

Primary hyperhidrosis is a relatively common disorder, affecting approximately 3% of the population. It affects both sexes similarly and in all age groups, varying only the starting age of symptoms according to the most affected part of the body:

childhood - plantar and palmar hyperhidrosis adolescence - axillary hyperhidrosis adult - craniofacial hyperhidrosis

There is a family history associated with between 12.5% and 56.5% of the participants, according to epidemiological studies.

Initially the subjects will be evaluated on the inclusion and exclusion criteria through screening and safety tests such as blood tests , ECG and tonometry, to confirm enrollment.

When included will be randomized into the corresponding study arm to start study treatment.

During the period of the study it will evaluate the efficacy parameters of the drug.

The treatment for each subject will be about 8 weeks. The inclusion period is foreseen for 6 months and may be extended or decreased according to the pace of inclusion.

The data are summarized according to the study group (per dose and per visit, if applicable) through appropriate descriptive statistics to the variable type. Frequency and percentage will be used for the variables.

The Adverse Events (AE) will be analyzed based on questioning by the investigators in relation to the AE experienced by the subjects. The orientation will be to the subject to note the symptom, the date and time that the event appeared.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Understanding, agreement and consent form signed;
• Literate;
• Confirmed diagnosis for primary hyperhidrosis;
• Screening tests at normal standards;
• Absence of pregnancy by Beta-human chorionic gonadotropin test;

Exclusion criteria

• Secondary Hyperhidrosis;
• Myasthenia gravis;
• Lactation;
• Hypersensitivity to oxybutynin;
• Use more than 500mg of caffeine;
• Alcoholism;
• Use of illicit drug;
• Changes in ECG (echocardiogram) or tonometry;
• Any clinical condition that the investigator considers clinically significant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Oxybutynin Chloride

Active Comparator group

Description:

* Tablet * Dose 5,0 or 10 mg/ day

Treatment:

Drug: Oxybutynin

Placebo

Placebo Comparator group

Description:

- Tablet

Treatment:

Drug: Placebo