Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis

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.

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.

Study Overview

• Status: Withdrawn
• Conditions: Hyperhidrosis
• Intervention / Treatment: Drug: Oxybutynin; Drug: Placebo

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.

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
  • São Paulo, Brazil, 05652-90
    • Hospital Israelita Albert Einstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Oxybutynin Chloride; Tablet; Dose 5,0 or 10 mg/ day	Drug: Oxybutynin; The doses will increase due to the absence/ lack of therapeutic response of the previous dose assessed during the study visits.
PLACEBO_COMPARATOR: Placebo; - Tablet	Drug: Placebo; The quantity of tablets will increase due to the absence/ lack of therapeutic response.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxybutynin Chloride efficacy	Evaluation of the therapeutic efficacy by Oxybutynin Hydrochloride in the treatment of primary hyperhidrosis.	6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.
• Collaborators: University of Sao Paulo; Hospital Israelita Albert Einstein
• Investigators: Principal Investigator: José R Milanez de Campos, Hospital Israelita Albert Einstein

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (ANTICIPATED): January 1, 2016
• Study Completion (ANTICIPATED): February 1, 2016

Study Registration Dates

• First Submitted: March 20, 2014
• First Submitted That Met QC Criteria: March 26, 2014
• First Posted (ESTIMATE): March 31, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): July 26, 2016
• Last Update Submitted That Met QC Criteria: July 25, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Hyperhidrosis; Oxybutynin
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Oxybutynin
• Other Study ID Numbers: CRT069