Clinical Trial: Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

Brief 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 Summary:

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.

Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.

Current Primary Outcome: Oxybutynin Chloride efficacy [ Time Frame: 6 weeks ]

Evaluation of the therapeutic efficacy by Oxybutynin Hydrochloride in the treatment of primary hyperhidrosis.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Cristália Produtos Químicos Farmacêuticos Ltda.

Dates:
Date Received: March 20, 2014
Date Started: December 2015
Date Completion: February 2016
Last Updated: July 25, 2016
Last Verified: July 2016