Clinical trial NCT02099695: Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hyperhidrosis
Keywords: Hyperhidrosis
Oxybutynin
Lead sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.
Sponsor class: INDUSTRY
Collaborators: name: Hospital Israelita Albert Einstein
name: University of Sao Paulo
First posted: 2014-03-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Oxybutynin Chloride efficacy
timeFrame: 6 weeks
Secondary outcomes:
measure: Perception of improvement
timeFrame: During treatment until week 8
measure: Evaluate therapeutic safety
timeFrame: During treatment until week 8
measure: Quality of life
timeFrame: During treatment until week 8
measure: Time of subject response
timeFrame: End of 8 weeks
measure: Duration of response
timeFrame: End of 8 weeks
measure: Evaluation between quality of life and groups
timeFrame: End of 8 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: José R Milanez de Campos
role: PRINCIPAL_INVESTIGATOR
References: