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Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (The company changed the strategy.)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.

Tracking Information
First Submitted Date  ICMJE March 20, 2014
First Posted Date  ICMJE March 31, 2014
Last Update Posted Date July 26, 2016
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2014)
Oxybutynin Chloride efficacy [ Time Frame: 6 weeks ]
Evaluation of the therapeutic efficacy by Oxybutynin Hydrochloride in the treatment of primary hyperhidrosis.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis
Official Title  ICMJE 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hyperhidrosis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Oxybutynin Chloride
    • Tablet
    • Dose 5,0 or 10 mg/ day
    Intervention: Drug: Oxybutynin
  • Placebo Comparator: Placebo
    - Tablet
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 25, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2014)
136
Estimated Study Completion Date  ICMJE February 2016
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02099695
Other Study ID Numbers  ICMJE CRT069
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Cristália Produtos Químicos Farmacêuticos Ltda.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Cristália Produtos Químicos Farmacêuticos Ltda.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Hospital Israelita Albert Einstein
  • University of Sao Paulo
Investigators  ICMJE
Principal Investigator: José R Milanez de Campos Hospital Israelita Albert Einstein
PRS Account Cristália Produtos Químicos Farmacêuticos Ltda.
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP