NCT01118429

Brief Summary

The objective of this study was to evaluate the effectiveness and patient satisfaction with the use of oxybutynin at low doses for treating axillary hyperhidrosis in a large series of patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

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

January 1, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 6, 2010

Completed
Last Updated

May 6, 2010

Status Verified

March 1, 2010

Enrollment Period

2.4 years

First QC Date

April 29, 2010

Last Update Submit

May 5, 2010

Conditions

Axillary HyperhidrosisOsmidrosis

Keywords

hyperhidrosisaxillaryosmidrosisoxybutynin

Outcome Measures

Primary Outcomes (2)

  • Effectiveness of treatment by a clinical questionnaire

    These evaluations were used to assess (1) the patients' clinical improvement in axillary hyperhidrosis, using a clinical questionnaire, published at 2003: de Campos JR, Kauffman P, Werebe Ede C, Andrade Filho LO, Kusniek S, Wolosker N, Jatene FB.Quality of life, before and after thoracic sympathectomy: report on 378 operated patients.Ann Thorac Surg. 2003 Sep;76(3):886-91

    6 weeks of treatment

  • Effectiveness of treatment using a clinical questionnaire

    These evaluations were used to assess (1) the patients' clinical improvement in axillary hyperhidrosis, using a clinical questionnaire: de Campos JR, Kauffman P, Werebe Ede C, Andrade Filho LO, Kusniek S, Wolosker N, Jatene FB.Quality of life, before and after thoracic sympathectomy: report on 378 operated patients.Ann Thorac Surg. 2003 Sep;76(3):886-91

    After 12 weeks of treatment

Secondary Outcomes (1)

  • Treatment of hyperhidrosis at other sites

    6 weeks

Study Arms (2)

Oxybutynin

EXPERIMENTAL

Oxybutynin was prescribed for 12 weeks, in progressively increasing doses throughout treatment. At their first visit, the patients were given 2.5 mg of oxybutynin into be taken once a day in the evening, were instructed to increase the dose to 2.5 mg twice a day from the eighth to the 42nd day, and to contact the doctor if they experienced any side effect. After this period they were seen in a second visit, and the dose was increased to 5 mg twice a day from the 43rd to the end of the 84thday, to when a third visit was scheduled.

Drug: Oxybutynin

Placebo

PLACEBO COMPARATOR

Oxybutyinine was prescribed for 12 weeks, in progressively increasing doses throughout treatment. At their first visit, the patients were given 2.5 mg of oxybutyn into be taken once a day in the evening, were instructed to increase the dose to 2.5 mg twice a day from the eighth to the 42nd day, and to contact the doctor if they experienced any side effect. After this period they were seen in a second visit, and the dose was increased to 5 mg twice a day from the 43rd to the end of the 84thday, to when a third visit was scheduled.

Drug: Placebo

Interventions

OxybutyninDRUG

Oxybutynin was prescribed for 12 weeks, in progressively increasing doses throughout treatment. At their first visit, the patients were given 2.5 mg of oxybutynin into be taken once a day in the evening, were instructed to increase the dose to 2.5 mg twice a day from the eighth to the 42nd day, and to contact the doctor if they experienced any side effect. After this period they were seen in a second visit, and the dose was increased to 5 mg twice a day from the 43rd to the end of the 84thday, to when a third visit was scheduled.

Oxybutynin
PlaceboDRUG

Oxybutyinine was prescribed for 12 weeks, in progressively increasing doses throughout treatment. At their first visit, the patients were given 2.5 mg of oxybutyn into be taken once a day in the evening, were instructed to increase the dose to 2.5 mg twice a day from the eighth to the 42nd day, and to contact the doctor if they experienced any side effect. After this period they were seen in a second visit, and the dose was increased to 5 mg twice a day from the 43rd to the end of the 84thday, to when a third visit was scheduled.

Placebo

Eligibility Criteria

Age14 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients with axillary hyperhidrosis

You may not qualify if:

  • glaucoma and micturition disorders, pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clinicas da FMUSP

São Paulo, São Paulo, 04534000, Brazil

Location

Related Publications (6)

  • Wolosker N, Yazbek G, de Campos JR, Munia MA, Kauffman P, Jatene FB, Puech-Leao P. Quality of life before surgery is a predictive factor for satisfaction among patients undergoing sympathectomy to treat hyperhidrosis. J Vasc Surg. 2010 May;51(5):1190-4. doi: 10.1016/j.jvs.2009.11.078. Epub 2010 Mar 29.

    PMID: 20299178BACKGROUND

  • de Campos JR, Wolosker N, Yazbek G, Munia MA, Kauffman P, Puech-Leao P, Jatene FB. Comparison of pain severity following video-assisted thoracoscopic sympathectomy: electric versus harmonic scalpels. Interact Cardiovasc Thorac Surg. 2010 Jun;10(6):919-22. doi: 10.1510/icvts.2009.225383. Epub 2010 Mar 16.

    PMID: 20233806BACKGROUND

  • Yazbek G, Wolosker N, Kauffman P, Campos JR, Puech-Leao P, Jatene FB. Twenty months of evolution following sympathectomy on patients with palmar hyperhidrosis: sympathectomy at the T3 level is better than at the T2 level. Clinics (Sao Paulo). 2009;64(8):743-9. doi: 10.1590/S1807-59322009000800006.

    PMID: 19690657BACKGROUND

  • Munia MA, Wolosker N, Kaufmann P, de Campos JR, Puech-Leao P. Sustained benefit lasting one year from T4 instead of T3-T4 sympathectomy for isolated axillary hyperhidrosis. Clinics (Sao Paulo). 2008 Dec;63(6):771-4. doi: 10.1590/s1807-59322008000600011.

    PMID: 19060999BACKGROUND

  • Wolosker N, Yazbek G, Ishy A, de Campos JR, Kauffman P, Puech-Leao P. Is sympathectomy at T4 level better than at T3 level for treating palmar hyperhidrosis? J Laparoendosc Adv Surg Tech A. 2008 Feb;18(1):102-6. doi: 10.1089/lap.2007.0030.

    PMID: 18266585BACKGROUND

  • Munia MA, Wolosker N, Kauffman P, de Campos JR, Puech-Leao P. A randomized trial of T3-T4 versus T4 sympathectomy for isolated axillary hyperhidrosis. J Vasc Surg. 2007 Jan;45(1):130-3. doi: 10.1016/j.jvs.2006.09.011.

    PMID: 17210397BACKGROUND

MeSH Terms

Conditions

Body OdorHyperhidrosis

Interventions

oxybutynin

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsSweat Gland DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Nelson Wolosker, MD, PhD

    Hospital das Clinicas, University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 29, 2010

First Posted

May 6, 2010

Study Start

January 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

May 6, 2010

Record last verified: 2010-03

Locations

BR(1)