Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis
Primary Purpose
Hyperhidrosis
Status
Withdrawn
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Oxybutynin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperhidrosis focused on measuring Hyperhidrosis, Oxybutynin
Eligibility 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.
Sites / Locations
- Hospital Israelita Albert Einstein
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Oxybutynin Chloride
Placebo
Arm Description
Tablet Dose 5,0 or 10 mg/ day
- Tablet
Outcomes
Primary Outcome Measures
Oxybutynin Chloride efficacy
Evaluation of the therapeutic efficacy by Oxybutynin Hydrochloride in the treatment of primary hyperhidrosis.
Secondary Outcome Measures
Perception of improvement
Evaluation of perception of improvement from the subject by completing a questionaire
Evaluate therapeutic safety
Evaluate therapeutic safety of the Oxybutynin Chloride by assessing possible adverse event
Quality of life
Evaluate the difference in subject's quality of life between the treatment groups
Time of subject response
Evaluation of average time the subject reaches response
Duration of response
Evaluate the duration of response
Evaluation between quality of life and groups
Evaluate the difference of quality of life in the end of treatment between the groups
Full Information
NCT ID
NCT02099695
First Posted
March 20, 2014
Last Updated
July 25, 2016
Sponsor
Cristália Produtos Químicos Farmacêuticos Ltda.
Collaborators
Hospital Israelita Albert Einstein, University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02099695
Brief Title
Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Withdrawn
Why Stopped
The company changed the strategy.
Study Start Date
December 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cristália Produtos Químicos Farmacêuticos Ltda.
Collaborators
Hospital Israelita Albert Einstein, University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis
Keywords
Hyperhidrosis, Oxybutynin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxybutynin Chloride
Arm Type
Active Comparator
Arm Description
Tablet
Dose 5,0 or 10 mg/ day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
- Tablet
Intervention Type
Drug
Intervention Name(s)
Oxybutynin
Intervention Description
The doses will increase due to the absence/ lack of therapeutic response of the previous dose assessed during the study visits.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The quantity of tablets will increase due to the absence/ lack of therapeutic response.
Primary Outcome Measure Information:
Title
Oxybutynin Chloride efficacy
Description
Evaluation of the therapeutic efficacy by Oxybutynin Hydrochloride in the treatment of primary hyperhidrosis.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Perception of improvement
Description
Evaluation of perception of improvement from the subject by completing a questionaire
Time Frame
During treatment until week 8
Title
Evaluate therapeutic safety
Description
Evaluate therapeutic safety of the Oxybutynin Chloride by assessing possible adverse event
Time Frame
During treatment until week 8
Title
Quality of life
Description
Evaluate the difference in subject's quality of life between the treatment groups
Time Frame
During treatment until week 8
Title
Time of subject response
Description
Evaluation of average time the subject reaches response
Time Frame
End of 8 weeks
Title
Duration of response
Description
Evaluate the duration of response
Time Frame
End of 8 weeks
Title
Evaluation between quality of life and groups
Description
Evaluate the difference of quality of life in the end of treatment between the groups
Time Frame
End of 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José R Milanez de Campos
Organizational Affiliation
Hospital Israelita Albert Einstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Israelita Albert Einstein
City
São Paulo
ZIP/Postal Code
05652-90
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis
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