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Trial record 47 of 166 for:    "Sweat Gland Disease"

Safety and Efficacy of an Anticholinergic Agent for Treatment of Primary Axillary Hyperhidrosis

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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

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.

Condition or disease Intervention/treatment Phase
Hyperhidrosis Drug: WL8713, 6 mg Drug: WL8713, 12 mg Drug: WL8713, 18 mg Drug: WL8713, 24 mg Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of An Anticholinergic Agent for the Treatment of Primary Axillary Hyperhidrosis
Study Start Date : December 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sweat

Arm Intervention/treatment
Experimental: WL8713, 6 mg
6 mg WL8713 administered daily
Drug: WL8713, 6 mg
Experimental: WL8713, 12 mg
12 mg WL8713 administered daily
Drug: WL8713, 12 mg
Experimental: WL8713, 18 mg
18 mg WL8713 administered daily
Drug: WL8713, 18 mg
Experimental: WL8713, 24 mg
24 mg WL8713 administered daily
Drug: WL8713, 24 mg
Placebo Comparator: Placebo
placebo administered daily
Drug: Placebo



Primary Outcome Measures :
  1. Gravimetric measurement of sweat production [ Time Frame: 6 weeks ]
    Change from baseline in mean (bilateral average) sweat weight at Week 6 (LOCF)


Secondary Outcome Measures :
  1. 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)

  2. Dermatology Life Quality Index (DLQI) scores [ Time Frame: 6 weeks ]
    Change from baseline in DLQI total score at Week 6 (LOCF)

  3. Global Assessment of Disease State responses [ Time Frame: 6 weeks ]
    Global Assessment of Disease State score at Week 6 (LOCF)



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02193139


Locations
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United States, California
Watson Clinical Site
San Diego, California, United States
Sponsors and Collaborators
Watson Pharmaceuticals

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Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02193139     History of Changes
Other Study ID Numbers: OH1304
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: August 6, 2015
Last Verified: November 2014

Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs