| April 29, 2010 |
| May 5, 2010 |
| January 2007 |
| June 2009 (final data collection date for primary outcome measure) |
- Effectiveness of treatment by a clinical questionnaire [ Time Frame: 6 weeks of treatment ] [ Designated as safety issue: No ]
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
- Effectiveness of treatment using a clinical questionnaire [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
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
|
| Same as current |
| Complete list of historical versions of study NCT01118429 on ClinicalTrials.gov Archive Site |
| Treatment of hyperhidrosis at other sites [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] These evaluations were used to assess (1) the patients' clinical improvement in hyperhidrosis at other sites, using a clinical questionnaire. |
| Same as current |
| Not Provided |
| Not Provided |
| |
| Use of Oxybutynin to Treat Axillary Hyperhidrosis |
| Use of Oxybutynin to Treat Axillary Hyperhidrosis |
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. |
| Not Provided |
| Interventional |
| Not Provided |
Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
- Axillary Hyperhidrosis
- Osmidrosis
|
- Drug: Oxybutynin
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: Placebo
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.
|
- Experimental: Oxybutynin
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.
Intervention: Drug: Oxybutynin
- Placebo Comparator: Placebo
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.
Intervention: Drug: Placebo
|
- 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. Epub 2010 Mar 29.
- 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 Mar 16; [Epub ahead of print]
- Yazbek G, Wolosker N, Kauffman P, de Campos JR, Puech-Leão 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.
- Munia MA, Wolosker N, Kaufmann P, de Campos JR, Puech-Leão 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.
- Wolosker N, Yazbek G, Ishy A, de Campos JR, Kauffman P, Puech-Leão 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.
- Munia MA, Wolosker N, Kauffman P, de Campos JR, Puech-Leão P. A randomized trial of T3-T4 versus T4 sympathectomy for isolated axillary hyperhidrosis. J Vasc Surg. 2007 Jan;45(1):130-3.
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| |
| Completed |
| 100 |
| June 2009 |
| June 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- patients with axillary hyperhidrosis
Exclusion Criteria:
- glaucoma and micturition disorders, pregnancy
|
| Both |
| 14 Years to 55 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Brazil |
| |
| NCT01118429 |
| 0083/10 |
| Yes |
| Nelson Wolosker, HCFMUSP |
| Grupo de Cirurgia Vascular |
| Not Provided
| Principal Investigator: |
Nelson Wolosker, MD, PhD |
Hospital das Clinicas, University of Sao Paulo |
|
|
| Grupo de Cirurgia Vascular |
| March 2010 |