Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis
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|ClinicalTrials.gov Identifier: NCT02099695|
Recruitment Status : Withdrawn (The company changed the strategy.)
First Posted : March 31, 2014
Last Update Posted : July 26, 2016
Treatment of primary hyperhidrosis through a comparative study between oxybutynin hydrochloride and placebo.
Hydrochloride may decrease the symptoms of hyperhidrosis improving the subject's quality of life.
|Condition or disease||Intervention/treatment||Phase|
|Hyperhidrosis||Drug: Oxybutynin Drug: Placebo||Phase 3|
Clinical Trial phase III, randomized, national, prospective, double-blind, multicenter, comparative between oxybutynin hydrochloride and placebo, to be held in participants aged over 18 years to evaluate the therapeutic efficacy and safety of oxybutynin chloride to systemic treatment of primary hyperhidrosis.
Primary hyperhidrosis is a relatively common disorder, affecting approximately 3% of the population. It affects both sexes similarly and in all age groups, varying only the starting age of symptoms according to the most affected part of the body:
childhood - plantar and palmar hyperhidrosis adolescence - axillary hyperhidrosis adult - craniofacial hyperhidrosis
There is a family history associated with between 12.5% and 56.5% of the participants, according to epidemiological studies.
Initially the subjects will be evaluated on the inclusion and exclusion criteria through screening and safety tests such as blood tests , ECG and tonometry, to confirm enrollment.
When included will be randomized into the corresponding study arm to start study treatment.
During the period of the study it will evaluate the efficacy parameters of the drug.
The treatment for each subject will be about 8 weeks. The inclusion period is foreseen for 6 months and may be extended or decreased according to the pace of inclusion.
The data are summarized according to the study group (per dose and per visit, if applicable) through appropriate descriptive statistics to the variable type. Frequency and percentage will be used for the variables.
The Adverse Events (AE) will be analyzed based on questioning by the investigators in relation to the AE experienced by the subjects. The orientation will be to the subject to note the symptom, the date and time that the event appeared.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Clinical Trial Phase III, Prospective, Randomized, Double-blind, Multicenter, National, Comparative Between Oxybutynin Chloride With Placebo to Evaluate the Efficacy and Safety for Systemic Treatment of Primary Hyperhidrosis.|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||February 2016|
Active Comparator: Oxybutynin Chloride
The doses will increase due to the absence/ lack of therapeutic response of the previous dose assessed during the study visits.
Placebo Comparator: Placebo
The quantity of tablets will increase due to the absence/ lack of therapeutic response.
- Oxybutynin Chloride efficacy [ Time Frame: 6 weeks ]Evaluation of the therapeutic efficacy by Oxybutynin Hydrochloride in the treatment of primary hyperhidrosis.
- Perception of improvement [ Time Frame: During treatment until week 8 ]Evaluation of perception of improvement from the subject by completing a questionaire
- Evaluate therapeutic safety [ Time Frame: During treatment until week 8 ]Evaluate therapeutic safety of the Oxybutynin Chloride by assessing possible adverse event
- Quality of life [ Time Frame: During treatment until week 8 ]Evaluate the difference in subject's quality of life between the treatment groups
- Time of subject response [ Time Frame: End of 8 weeks ]Evaluation of average time the subject reaches response
- Duration of response [ Time Frame: End of 8 weeks ]Evaluate the duration of response
- Evaluation between quality of life and groups [ Time Frame: End of 8 weeks ]Evaluate the difference of quality of life in the end of treatment between the groups
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099695
|Hospital Israelita Albert Einstein|
|São Paulo, Brazil, 05652-90|
|Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo|
|São Paulo, Brazil|
|Principal Investigator:||José R Milanez de Campos||Hospital Israelita Albert Einstein|