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Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis

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ClinicalTrials.gov Identifier: NCT02099695
Recruitment Status : Withdrawn (The company changed the strategy.)
First Posted : March 31, 2014
Last Update Posted : July 26, 2016
Sponsor:
Collaborators:
Hospital Israelita Albert Einstein
University of Sao Paulo
Information provided by (Responsible Party):
Cristália Produtos Químicos Farmacêuticos Ltda.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hyperhidrosis Drug: Oxybutynin Drug: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2015
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Oxybutynin Chloride efficacy [ Time Frame: 6 weeks ]
    Evaluation of the therapeutic efficacy by Oxybutynin Hydrochloride in the treatment of primary hyperhidrosis.


Secondary Outcome Measures :
  1. Perception of improvement [ Time Frame: During treatment until week 8 ]
    Evaluation of perception of improvement from the subject by completing a questionaire

  2. Evaluate therapeutic safety [ Time Frame: During treatment until week 8 ]
    Evaluate therapeutic safety of the Oxybutynin Chloride by assessing possible adverse event

  3. Quality of life [ Time Frame: During treatment until week 8 ]
    Evaluate the difference in subject's quality of life between the treatment groups

  4. Time of subject response [ Time Frame: End of 8 weeks ]
    Evaluation of average time the subject reaches response

  5. Duration of response [ Time Frame: End of 8 weeks ]
    Evaluate the duration of response

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099695


Locations
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Brazil
Hospital Israelita Albert Einstein
São Paulo, Brazil, 05652-90
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil
Sponsors and Collaborators
Cristália Produtos Químicos Farmacêuticos Ltda.
Hospital Israelita Albert Einstein
University of Sao Paulo
Investigators
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Principal Investigator: José R Milanez de Campos Hospital Israelita Albert Einstein
More Information
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Responsible Party: Cristália Produtos Químicos Farmacêuticos Ltda.
ClinicalTrials.gov Identifier: NCT02099695    
Other Study ID Numbers: CRT069
First Posted: March 31, 2014    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016
Keywords provided by Cristália Produtos Químicos Farmacêuticos Ltda.:
Hyperhidrosis
Oxybutynin
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases
Oxybutynin
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents