NCT02099695

Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis

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.

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hyperhidrosis

Interventions

Type	Name	Description
DRUG	Oxybutynin	The doses will increase due to the absence/ lack of therapeutic response of the previous dose assessed during the study visits.
DRUG	Placebo	The quantity of tablets will increase due to the absence/ lack of therapeutic response.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-01-01
• Completion: 2016-02-01
• First posted: 2014-03-31
• Last updated: 2016-07-26

Locations

2 sites across 1 country: Brazil