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Treatment of Hyperhidrosis With Oxybutynin (H²O)

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: NCT01855256
Recruitment Status : Completed
First Posted : May 16, 2013
Last Update Posted : July 8, 2014
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Brest

Tracking Information
First Submitted Date  ICMJE May 13, 2013
First Posted Date  ICMJE May 16, 2013
Last Update Posted Date July 8, 2014
Study Start Date  ICMJE June 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2013)
Evaluation of the effectiveness of oxybutynin in hyperhidrosis [ Time Frame: 6 weeks ]
Two scales are used for this evaluation (Hyperhydrosis Disease Severity Scale and Dermatology Life Quality Index )
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2013)
Safety evaluation of treatment in this indication [ Time Frame: 6 weeks ]
Number of Participants with Adverse Events will be followed.
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 Treatment of Hyperhidrosis With Oxybutynin
Official Title  ICMJE Treatment of Hyperhidrosis With Oxybutynin: a Randomized Controlled Double Blind Against Placebo
Brief Summary Evaluation of the effectiveness of oxybutynin in hyperhidrosis
Detailed Description Not Provided
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
    Oxybutynin is started at a dose of 2.5 mg / day and increased gradually until an effective dose without exceed 7.5 mg / day up to 6 weeks.
  • Drug: Placebo
    Placebo is started at a dose of 2.5 mg / day and increased gradually until an effective dose without exceed 7.5 mg / day up to 6 weeks.
Study Arms  ICMJE
  • Experimental: oxybutynin
    Oxybutynin was done at 2.5 mg/day from day 1 to day 4, then at 5 mg/day from day 5 to day 7 and at 7.5 mg/day from day 8 to the end of the 6 weeks.
    Intervention: Drug: Oxybutynin
  • Placebo Comparator: Placebo
    Placebo was done at 2.5 mg/day from day 1 to day 4, then at 5 mg/day from day 5 to day 7 and at 7.5 mg/day from day 8 to the end of the 6 weeks.
    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: February 25, 2014)
62
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2013)
60
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age greater than 18 years
  • Patient affiliated to social security or beneficiary of such a regime
  • Patient able to consent
  • Patient with hyperhidrosis, generalized or localized (palmar, plantar, axillary) and whose score HDSS (Hyperidrosis Disease Severity Scale) is greater than two.

Exclusion Criteria:

  • Age less than 18 years
  • Patient who can't be followed
  • Patient participating in another clinical trial
  • Pregnant
  • Woman breastfeeding
  • Hypersensitivity to oxybutynin or any of the excipients
  • Risk of urinary retention related disorders uretroprostatiques
  • Intestinal obstruction
  • Toxic megacolon
  • Intestinal atony
  • Severe Ulcerative Colitis
  • Myasthenia
  • Closure glaucoma the anterior chamber angle or slightly deep
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 France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01855256
Other Study ID Numbers  ICMJE RB 12.035 H²O
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Hospital, Brest
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Brest
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Ministry of Health, France
Investigators  ICMJE
Principal Investigator: Martine SCHOLLHAMMER, MD ADBO
PRS Account University Hospital, Brest
Verification Date July 2014

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