Treatment of Hyperhidrosis With Oxybutynin

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

PHASE3

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-03-31

Brief Summary

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Evaluation of the effectiveness of oxybutynin in hyperhidrosis

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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

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Oxybutynin

Intervention Type DRUG

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.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No