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

NCT ID: NCT02193139

Last Updated: 2015-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-06-30

Brief Summary

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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

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Conditions

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Hyperhidrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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WL8713, 6 mg

6 mg WL8713 administered daily

Group Type EXPERIMENTAL

WL8713, 6 mg

Intervention Type DRUG

WL8713, 12 mg

12 mg WL8713 administered daily

Group Type EXPERIMENTAL

WL8713, 12 mg

Intervention Type DRUG

WL8713, 18 mg

18 mg WL8713 administered daily

Group Type EXPERIMENTAL

WL8713, 18 mg

Intervention Type DRUG

WL8713, 24 mg

24 mg WL8713 administered daily

Group Type EXPERIMENTAL

WL8713, 24 mg

Intervention Type DRUG

Placebo

placebo administered daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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WL8713, 6 mg

Intervention Type DRUG

WL8713, 12 mg

Intervention Type DRUG

WL8713, 18 mg

Intervention Type DRUG

WL8713, 24 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Watson Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Watson Clinical Site

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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OH1304

Identifier Type: -

Identifier Source: org_study_id

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