NCT01310712

Brief Summary

Video-assisted thoracic sympathectomy (VATS) provides excellent resolution of palmar and axillary hyperhidrosis but is associated with compensatory hyperhidrosis. Low doses of Oxybutynin can be used to treat palmar hyperhidrosis with fewer side effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2011

Completed
Last Updated

September 22, 2011

Status Verified

March 1, 2011

Enrollment Period

2 months

First QC Date

March 7, 2011

Last Update Submit

September 21, 2011

Conditions

Hyperhidrosis

Keywords

hyperhidrosisoxybutynin

Outcome Measures

Primary Outcomes (1)

  • Improvement of Quality of life in patients with hyperhidrosis with the use of oxybutynin

    Using a Quality of life protocol we will study if patients with hyperhidrosis using oxybutynin have an improvement in their quality of life

    6 weeks

Secondary Outcomes (1)

  • The use of oxybutynin diminishes hyperhidrosis

    6 weeks

Study Arms (2)

oxybutynin

EXPERIMENTAL

patients will receive in the end of the treatment, 10 mg of oxybutynin a day

Drug: Oxybutynin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

OxybutyninDRUG

5 mg every 12 hours for 6 weeks

oxybutynin
placeboDRUG

placebo twice a day for 42 days.

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients with hyperhidrosis

You may not qualify if:

  • Glaucoma and pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clinicas da FMUSP

São Paulo, São Paulo, 05679040, Brazil

Location

MeSH Terms

Conditions

Hyperhidrosis

Interventions

oxybutynin

Condition Hierarchy (Ancestors)

Sweat Gland DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • WOLOSKER NELSON, Md, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 7, 2011

First Posted

March 8, 2011

Study Start

December 1, 2010

Primary Completion

February 1, 2011

Study Completion

March 1, 2011

Last Updated

September 22, 2011

Record last verified: 2011-03

Locations

BR(1)