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Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis

Information source: Cristália Produtos Químicos Farmacêuticos Ltda.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hyperhidrosis

Intervention: Oxybutynin (Drug); Placebo (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Cristália Produtos Químicos Farmacêuticos Ltda.

Official(s) and/or principal investigator(s):
José R Milanez de Campos, Principal Investigator, Affiliation: Hospital Israelita Albert Einstein

Overall contact:
Débora G Rodrigues, Phone: 55-11-3723-6489, Email: debora.rodrigues@cristalia.com.br


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.

Clinical Details

Official title: Clinical Trial Phase III, Prospective, Randomized, Double-blind, Multicenter, National, Comparative Between Oxybutynin Chloride With Placebo to Evaluate the Efficacy and Safety for Systemic Treatment of Primary Hyperhidrosis.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Oxybutynin Chloride efficacy

Secondary outcome:

Perception of improvement

Evaluate therapeutic safety

Quality of life

Time of subject response

Duration of response

Evaluation between quality of life and groups

Detailed 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Débora G Rodrigues, Phone: 55-11-3723-6489, Email: debora.rodrigues@cristalia.com.br

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil; Not yet recruiting

Hospital Israelita Albert Einstein, São Paulo 05652-90, Brazil; Not yet recruiting

Additional Information

Starting date: September 2015
Last updated: July 27, 2015

Page last updated: August 23, 2015

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