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Safety and Efficacy of an Anticholinergic Agent for Treatment of Primary Axillary 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: NCT02193139
Recruitment Status : Completed
First Posted : July 17, 2014
Last Update Posted : August 6, 2015
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE June 29, 2014
First Posted Date  ICMJE July 17, 2014
Last Update Posted Date August 6, 2015
Study Start Date  ICMJE December 2013
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2014)
Gravimetric measurement of sweat production [ Time Frame: 6 weeks ]
Change from baseline in mean (bilateral average) sweat weight at Week 6 (LOCF)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02193139 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2014)
  • Hyperhidrosis Disease Severity Scale (HDSS) scores [ Time Frame: 6 weeks ]
    Percentage of subjects with a change from baseline in HDSS scores of at least -2 points at Week 6 (LOCF)
  • Dermatology Life Quality Index (DLQI) scores [ Time Frame: 6 weeks ]
    Change from baseline in DLQI total score at Week 6 (LOCF)
  • Global Assessment of Disease State responses [ Time Frame: 6 weeks ]
    Global Assessment of Disease State score at Week 6 (LOCF)
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 Safety and Efficacy of an Anticholinergic Agent for Treatment of Primary Axillary Hyperhidrosis
Official Title  ICMJE A Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of An Anticholinergic Agent for the Treatment of Primary Axillary Hyperhidrosis
Brief Summary This Phase 2 study is designed to evaluate multiple doses of an anticholinergic-containing medication and identify the dose or doses that may effectively reduce axillary sweating in hyperhidrotic subjects. The anticholinergic agent being studied is designated WL8713.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hyperhidrosis
Intervention  ICMJE
  • Drug: WL8713, 6 mg
  • Drug: WL8713, 12 mg
  • Drug: WL8713, 18 mg
  • Drug: WL8713, 24 mg
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: WL8713, 6 mg
    6 mg WL8713 administered daily
    Intervention: Drug: WL8713, 6 mg
  • Experimental: WL8713, 12 mg
    12 mg WL8713 administered daily
    Intervention: Drug: WL8713, 12 mg
  • Experimental: WL8713, 18 mg
    18 mg WL8713 administered daily
    Intervention: Drug: WL8713, 18 mg
  • Experimental: WL8713, 24 mg
    24 mg WL8713 administered daily
    Intervention: Drug: WL8713, 24 mg
  • Placebo Comparator: Placebo
    placebo administered daily
    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: November 13, 2014)
195
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2014)
150
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy volunteers with primary axillary hyperhidrosis
  • Poor quality of life rating on the Hyperhidrosis Disease Severity Scale (score of 3 or 4)
  • Has a baseline gravimetric measurement of spontaneous resting sweat production of ≥100 mg/10 min at room at room temperature in at least one axilla
  • Meets at least two of the following criteria (self-reported):

    • sweating is bilateral and symmetrical
    • excessive sweating impairs daily activities
    • subject experiences at least one sweating episode per week
    • excessive sweating onset was earlier than age 25 years
    • has a positive family history for excessive sweating
    • cessation of sweating during sleep
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02193139
Other Study ID Numbers  ICMJE OH1304
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Watson Pharmaceuticals
Study Sponsor  ICMJE Watson Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Watson Pharmaceuticals
Verification Date November 2014

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