Hyperhidrosis | Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis
Hyperhidrosis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:OxybutyninThe doses will increase due to the absence/ lack of therapeutic response of the previous dose assessed during the study visits.
Drug:PlaceboThe quantity of tablets will increase due to the absence/ lack of therapeutic response.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Oxybutynin ChlorideTablet Dose 5,0 or 10 mg/ day
Start Date: December 2015
Completed Date: February 2016
Phase: Phase 3
Primary Outcome: Oxybutynin Chloride efficacy
Secondary Outcome: Perception of improvement
Study sponsors, principal investigator, and references
Principal Investigator: José R Milanez de Campos
Lead Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.
Collaborator: Hospital Israelita Albert Einstein