Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis

• Status: Withdrawn
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.
• Collaborators: Hospital Israelita Albert Einstein; University of Sao Paulo
• Treatments: Mandelic Acids; Oxybutynin

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.