Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study
NCT ID: NCT01310712
Last Updated: 2011-09-22
Study Results
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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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2010-12-31
2011-03-31
Brief Summary
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Detailed Description
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Purpose: The objective of this study is to evaluate the effectiveness and patient satisfaction with the use of oxybutynin at low doses comparing to placebo for treating palmar hyperhidrosis.
Methods: This is a prospective, randomized and controlled study. From December 2010 to february 2011, 50 consecutive patients with palmar hyperhidrosis were treated with oxybutynin or placebo. Data were collected from 50 patients, and 5 (10,0%) patients were lost to follow-up. During the first week, patients received 2.5 mg of oxybutynin once a day in the evening. From the 8th to the 42nd day, they received 2.5 mg twice a day, and from the 43rd day to the end of the 12th week, they received 5 mg twice a day. All of the patients underwent 2 evaluations: before and after (12 weeks) the oxybutynin treatment, using a clinical questionnaire; and a clinical protocol for quality of life (QOL).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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oxybutynin
patients will receive in the end of the treatment, 10 mg of oxybutynin a day
Oxybutynin
5 mg every 12 hours for 6 weeks
Placebo
Placebo
placebo
placebo twice a day for 42 days.
Interventions
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Oxybutynin
5 mg every 12 hours for 6 weeks
placebo
placebo twice a day for 42 days.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
60 Years
ALL
Yes
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Nelson Wolosker
MD, PhD
Principal Investigators
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WOLOSKER NELSON, Md, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
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Hospital das Clinicas da FMUSP
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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University of Sao Paulo
Identifier Type: -
Identifier Source: org_study_id