Study Stopped
The company changed the strategy.
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.
1 other identifier
interventional
N/A
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2015
Shorter than P25 for phase_3
2 active sites
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
First Submitted
Initial submission to the registry
March 20, 2014
CompletedFirst Posted
Study publicly available on registry
March 31, 2014
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedJuly 26, 2016
July 1, 2016
1 month
March 20, 2014
July 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oxybutynin Chloride efficacy
Evaluation of the therapeutic efficacy by Oxybutynin Hydrochloride in the treatment of primary hyperhidrosis.
6 weeks
Secondary Outcomes (6)
Perception of improvement
During treatment until week 8
Evaluate therapeutic safety
During treatment until week 8
Quality of life
During treatment until week 8
Time of subject response
End of 8 weeks
Duration of response
End of 8 weeks
- +1 more secondary outcomes
Study Arms (2)
Oxybutynin Chloride
ACTIVE COMPARATOR* Tablet * Dose 5,0 or 10 mg/ day
Placebo
PLACEBO COMPARATOR\- Tablet
Interventions
The doses will increase due to the absence/ lack of therapeutic response of the previous dose assessed during the study visits.
The quantity of tablets will increase due to the absence/ lack of therapeutic response.
Eligibility Criteria
You may qualify if:
- Understanding, agreement and consent form signed;
- Literate;
- Confirmed diagnosis for primary hyperhidrosis;
- Screening tests at normal standards;
- Absence of pregnancy by Beta-human chorionic gonadotropin test;
You may not qualify if:
- Secondary Hyperhidrosis;
- Myasthenia gravis;
- Lactation;
- Hypersensitivity to oxybutynin;
- Use more than 500mg of caffeine;
- Alcoholism;
- Use of illicit drug;
- Changes in ECG (echocardiogram) or tonometry;
- Any clinical condition that the investigator considers clinically significant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cristália Produtos Químicos Farmacêuticos Ltda.lead
- Hospital Israelita Albert Einsteincollaborator
- University of Sao Paulocollaborator
Study Sites (2)
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05652-90, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
José R Milanez de Campos
Hospital Israelita Albert Einstein
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2014
First Posted
March 31, 2014
Study Start
December 1, 2015
Primary Completion
January 1, 2016
Study Completion
February 1, 2016
Last Updated
July 26, 2016
Record last verified: 2016-07