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A Study to Compare Oxybutynin to a Placebo in Women and the Effect on Plantar Hyperhidrosis

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01328015
First received: March 29, 2011
Last updated: April 1, 2011
Last verified: November 2010
History of Changes
  Purpose

A study in which the experimental treatment procedure is compared to a standard (control) treatment, The use of oxybutynin in the late postoperative thoracic sympathectomy for women:

  1. To Evaluate the effect of oxybutynin on plantar hyperhidrosis.
  2. To evaluate the effect of oxybutynin in compensatory hyperhidrosis.
  3. To compare the results of questionnaires on quality of life and specific for hyperhidrosis to the results of TEWL.

Condition Intervention Phase
Hyperhidrosis
 Drug: Oxybutynin 5 mg pills
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Oxybutynin in Women After Thoracoscopic Sympathectomy and the Effect on Plantar Hyperhidrosis

Resource links provided by NLM:

MedlinePlus related topics: Sweat
U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • To evaluate the effect of oxybutynin in plantar hyperhidrosis [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
    Apply the questionnaires of quality of life, specific ones for hyperhidrosis and TEWL before in patients with persistence of plantar sweating after thoracic sympathectomy. After continuous use of oxybutynin for a month, repeated them for comparison.


Secondary Outcome Measures:
  • To evaluate the effect of oxybutynin in compensatory hyperhidrosis [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
    Apply the questionnaires of quality of life, specific ones for hyperhidrosis and TEWL before in patients with persistence of plantar sweating after thoracic sympathectomy. After continuous use of oxybutynin for a month, repeated them for comparison.


Enrollment: 32
Study Start Date: March 2010
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oxybuynin, hyperhidrosis Drug: Oxybutynin 5 mg pills

½ pill oral 12/12h for 3 days

01 ½ pills oral morning and evening for 3 days Continue 1 pill oral 2x/day for three weeks.

Other Name: anticholinergic drugs
Placebo Comparator: placebo - sugar pill Drug: Oxybutynin 5 mg pills

½ pill oral 12/12h for 3 days

01 ½ pills oral morning and evening for 3 days Continue 1 pill oral 2x/day for three weeks.

Other Name: anticholinergic drugs

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women with persistent plantar hyperhidrosis with limitation to their usual activities.

Exclusion Criteria:

  • pregnancy,
  • breastfeeding,
  • glaucoma,
  • use of tricyclic medications,
  • prior use of anticholinergic
  • side effects exacerbated, such as diarrhea, gastritis, constipation or dry mouth.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328015

Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Altair S Costa Jr, MD Federal University of Sao Paulo
  More Information

Publications:

Responsible Party: Altair da Silva Costa Junior, Federal University of São Paulo - Thoracic surgery departament
ClinicalTrials.gov Identifier: NCT01328015     History of Changes
Other Study ID Numbers: Oxybutynin and Hyperhidrosis
Study First Received: March 29, 2011
Last Updated: April 1, 2011
Health Authority: Brazil: Ethics Committee
Brazil: Ministry of Health

Keywords provided by Federal University of São Paulo:
hyperhidrosis
oxybutynin
plantar sweating
compensatory sweating

Additional relevant MeSH terms:
Hyperhidrosis
Sweat Gland Diseases
Skin Diseases
Oxybutynin
Cholinergic Antagonists
Parasympatholytics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013