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Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study

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: NCT01310712
Recruitment Status : Completed
First Posted : March 8, 2011
Last Update Posted : September 22, 2011
Sponsor:
Information provided by (Responsible Party):
Nelson Wolosker, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE March 7, 2011
First Posted Date  ICMJE March 8, 2011
Last Update Posted Date September 22, 2011
Study Start Date  ICMJE December 2010
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2011)		 Improvement of Quality of life in patients with hyperhidrosis with the use of oxybutynin [ Time Frame: 6 weeks ]
Using a Quality of life protocol we will study if patients with hyperhidrosis using oxybutynin have an improvement in their quality of life
Original Primary Outcome Measures  ICMJE
 (submitted: March 7, 2011)		 Improvement of Quality of life in patients with hyperhidrosis with the use of oxybutinin [ Time Frame: 6 weeks ]
Using a Quality of life protocol we will study if patients with hyperhidrosis using oxybutinin have an improvement in their quality of life
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2011)		 The use of oxybutynin diminishes hyperhidrosis [ Time Frame: 6 weeks ]
if the use of oxybutynin diminishes hyperhidrosis
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 Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study
Official Title  ICMJE Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study.
Brief Summary Video-assisted thoracic sympathectomy (VATS) provides excellent resolution of palmar and axillary hyperhidrosis but is associated with compensatory hyperhidrosis. Low doses of Oxybutynin can be used to treat palmar hyperhidrosis with fewer side effects.
Detailed Description

Introduction: Video-assisted thoracic sympathectomy (VATS) provides excellent resolution of palmar and axillary hyperhidrosis but is associated with compensatory hyperhidrosis. Low doses of Oxybutynin can be used to treat palmar hyperhidrosis with fewer side effects.

Purpose: The objective of this study is to evaluate the effectiveness and patient satisfaction with the use of oxybutynin at low doses comparing to placebo for treating palmar hyperhidrosis.

Methods: This is a prospective, randomized and controlled study. From December 2010 to february 2011, 50 consecutive patients with palmar hyperhidrosis were treated with oxybutynin or placebo. Data were collected from 50 patients, and 5 (10,0%) patients were lost to follow-up. During the first week, patients received 2.5 mg of oxybutynin once a day in the evening. From the 8th to the 42nd day, they received 2.5 mg twice a day, and from the 43rd day to the end of the 12th week, they received 5 mg twice a day. All of the patients underwent 2 evaluations: before and after (12 weeks) the oxybutynin treatment, using a clinical questionnaire; and a clinical protocol for quality of life (QOL).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Hyperhidrosis
Intervention  ICMJE
  • Drug: Oxybutynin
    5 mg every 12 hours for 6 weeks
  • Drug: placebo
    placebo twice a day for 42 days.
Study Arms  ICMJE
  • Experimental: oxybutynin
    patients will receive in the end of the treatment, 10 mg of oxybutynin a day
    Intervention: Drug: Oxybutynin
  • Placebo Comparator: Placebo
    Placebo
    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 Completed
Actual Enrollment  ICMJE
 (submitted: July 5, 2011)		 50
Original Actual Enrollment  ICMJE
 (submitted: March 7, 2011)		 2
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients with hyperhidrosis

Exclusion Criteria:

  • Glaucoma and pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT01310712
Other Study ID Numbers  ICMJE University of Sao Paulo
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Nelson Wolosker, University of Sao Paulo
Original Responsible Party Nelson Wolosker, Assistant Professor from University of Sao Paulo Medical School
Current Study Sponsor  ICMJE University of Sao Paulo
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: WOLOSKER NELSON, Md, PhD University of Sao Paulo
PRS Account University of Sao Paulo
Verification Date March 2011

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