Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis

Hyperhidrosis Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02099695
• Other study ID #: CRT069
• Status: Withdrawn
• Phase: Phase 3
• First received: March 20, 2014
• Last updated: July 25, 2016
• Start date: December 2015
• Est. completion date: February 2016

Study information

• Verified date: July 2016
• Source: Cristália Produtos Químicos Farmacêuticos Ltda.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperhidrosis

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo
Brazil	Hospital Israelita Albert Einstein	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
Cristália Produtos Químicos Farmacêuticos Ltda.	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxybutynin Chloride efficacy	Evaluation of the therapeutic efficacy by Oxybutynin Hydrochloride in the treatment of primary hyperhidrosis.	6 weeks	No
Secondary	Perception of improvement	Evaluation of perception of improvement from the subject by completing a questionaire	During treatment until week 8	Yes
Secondary	Evaluate therapeutic safety	Evaluate therapeutic safety of the Oxybutynin Chloride by assessing possible adverse event	During treatment until week 8	Yes
Secondary	Quality of life	Evaluate the difference in subject's quality of life between the treatment groups	During treatment until week 8	Yes
Secondary	Time of subject response	Evaluation of average time the subject reaches response	End of 8 weeks	Yes
Secondary	Duration of response	Evaluate the duration of response	End of 8 weeks	Yes
Secondary	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	Yes