Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 2016

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.

Interventions

  • Drug: Oxybutynin
    • The doses will increase due to the absence/ lack of therapeutic response of the previous dose assessed during the study visits.
  • Drug: Placebo
    • The quantity of tablets will increase due to the absence/ lack of therapeutic response.

Arms, Groups and Cohorts

  • Active Comparator: Oxybutynin Chloride
    • Tablet Dose 5,0 or 10 mg/ day
  • Placebo Comparator: Placebo
    • - Tablet

Clinical Trial Outcome Measures

Primary Measures

  • Oxybutynin Chloride efficacy
    • Time Frame: 6 weeks
    • Evaluation of the therapeutic efficacy by Oxybutynin Hydrochloride in the treatment of primary hyperhidrosis.

Secondary Measures

  • Perception of improvement
    • Time Frame: During treatment until week 8
    • Evaluation of perception of improvement from the subject by completing a questionaire
  • Evaluate therapeutic safety
    • Time Frame: During treatment until week 8
    • Evaluate therapeutic safety of the Oxybutynin Chloride by assessing possible adverse event
  • Quality of life
    • Time Frame: During treatment until week 8
    • Evaluate the difference in subject’s quality of life between the treatment groups
  • Time of subject response
    • Time Frame: End of 8 weeks
    • Evaluation of average time the subject reaches response
  • Duration of response
    • Time Frame: End of 8 weeks
    • Evaluate the duration of response
  • Evaluation between quality of life and groups
    • Time Frame: End of 8 weeks
    • Evaluate the difference of quality of life in the end of treatment between the groups

Participating in This Clinical Trial

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.
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Cristália Produtos Químicos Farmacêuticos Ltda.
    • Collaborator
      • Hospital Israelita Albert Einstein
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • José R Milanez de Campos, Principal Investigator, Hospital Israelita Albert Einstein

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