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
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.
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 improvementEvaluate 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Débora G Rodrigues, Phone: 55-11-3723-6489, Email: debora.rodrigues@cristalia.com.br
Hospital das ClÃnicas 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
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