HyperhidrosisPhase 3NCT02099695
Evaluate the Efficacy of Oxybutynin Chloride in Patients With Primary Hyperhidrosis
A Phase 3 study testing Oxybutynin in people with Hyperhidrosis, run by Cristália Produtos Químicos Farmacêuticos Ltda. at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperhidrosis
- What is being tested?
- Oxybutynin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesBrazil
- Study dates
- Dec 2015to Feb 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- Secondary Hyperhidrosis;
- Myasthenia gravis;
- Lactation;
- Hypersensitivity to oxybutynin;
- Use more than 500mg of caffeine;
- Alcoholism;
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- Use of illicit drug;
- Changes in ECG (echocardiogram) or tonometry;
- Any clinical condition that the investigator considers clinically significant.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05652-90
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo
About this study
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.
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.
Read the 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
- Being tested
- Oxybutynin, Placebo
- Keywords
- Hyperhidrosis, Oxybutynin
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxybutyninDrug
The doses will increase due to the absence/ lack of therapeutic response of the previous dose assessed during the study visits.
PlaceboDrug
The quantity of tablets will increase due to the absence/ lack of therapeutic response.
| Study group | Role | What they receive |
|---|---|---|
| Oxybutynin Chloride | Active comparator | * Tablet
* Dose 5,0 or 10 mg/ day Receives: Drug: Oxybutynin |
| Placebo | Placebo comparator | - Tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxybutynin Chloride efficacy
Evaluation of the therapeutic efficacy by Oxybutynin Hydrochloride in the treatment of primary hyperhidrosis.
Measured: 6 weeks
Secondary outcomes (6)
Perception of improvement
Evaluation of perception of improvement from the subject by completing a questionaire
Measured: During treatment until week 8
Evaluate therapeutic safety
Evaluate therapeutic safety of the Oxybutynin Chloride by assessing possible adverse event
Measured: During treatment until week 8
Quality of life
Evaluate the difference in subject's quality of life between the treatment groups
Measured: During treatment until week 8
Time of subject response
Evaluation of average time the subject reaches response
Measured: End of 8 weeks
Duration of response
Evaluate the duration of response
Measured: End of 8 weeks
Evaluation between quality of life and groups
Evaluate the difference of quality of life in the end of treatment between the groups
Measured: End of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startDec 2015
- Primary completionJan 2016 (estimated)
- Study completionFeb 2016 (estimated)
Why it stopped: The company changed the strategy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperhidrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Israelita Albert Einstein, University of Sao Paulo
- Responsible party
- Sponsor
- Investigators
- José R Milanez de Campos, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099695
- Sponsor's protocol ID
- CRT069
- Status last verified
- Jul 2016
- First submitted
- 20 Mar 2014
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02099695
- Acronym / sponsor ID
- CRT069
- Conditions
- Hyperhidrosis
- Keywords
- Hyperhidrosis, Oxybutynin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The company changed the strategy.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.Industry (pharma, biotech, devices)
- Collaborators
- Hospital Israelita Albert Einstein, University of Sao Paulo
- Study start
- Dec 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 31 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxybutynin Chloride | Active comparator | Drug: Oxybutynin* Tablet * Dose 5,0 or 10 mg/ day |
| Placebo | Placebo comparator | Drug: Placebo- Tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (9 listed)
- Secondary Hyperhidrosis;
- Myasthenia gravis;
- Lactation;
- Hypersensitivity to oxybutynin;
- Use more than 500mg of caffeine;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxybutyninThe doses will increase due to the absence/ lack of therapeutic response of the previous dose assessed during the study visits. | Drug | Oxybutynin Chloride |
| PlaceboThe quantity of tablets will increase due to the absence/ lack of therapeutic response. | Drug | Placebo |
Primary outcome
Oxybutynin Chloride efficacy
Time frame: 6 weeks
Evaluation of the therapeutic efficacy by Oxybutynin Hydrochloride in the treatment of primary hyperhidrosis.
6 secondary outcomes
Perception of improvement
Time frame: During treatment until week 8
Evaluate therapeutic safety
Time frame: During treatment until week 8
Quality of life
Time frame: During treatment until week 8
Time of subject response
Time frame: End of 8 weeks
Duration of response
Time frame: End of 8 weeks
Evaluation between quality of life and groups
Time frame: End of 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José R Milanez de Campos principal investigator
Hospital Israelita Albert Einstein
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxybutynin in people with Hyperhidrosis, run by Cristália Produtos Químicos Farmacêuticos Ltda. at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxybutynin Chloride efficacy (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.