Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis

NCT ID: NCT02099695

Last Updated: 2016-07-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-02-29

Brief Summary

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.

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.

Conditions

Hyperhidrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Oxybutynin Chloride

• Tablet
• Dose 5,0 or 10 mg/ day

Group Type: ACTIVE_COMPARATOR

Oxybutynin

Intervention Type: DRUG

The doses will increase due to the absence/ lack of therapeutic response of the previous dose assessed during the study visits.

Placebo

\- Tablet

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The quantity of tablets will increase due to the absence/ lack of therapeutic response.

Interventions

Oxybutynin

The doses will increase due to the absence/ lack of therapeutic response of the previous dose assessed during the study visits.

Intervention Type: DRUG

Placebo

The quantity of tablets will increase due to the absence/ lack of therapeutic response.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Israelita Albert Einstein

OTHER

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: collaborator

Cristália Produtos Químicos Farmacêuticos Ltda.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

José R Milanez de Campos

Role: PRINCIPAL_INVESTIGATOR

Hospital Israelita Albert Einstein

Locations

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

CRT069

Identifier Type: -

Identifier Source: org_study_id