Heat EffectEarly Phase 1NCT03205605

Effect of Heat on Oxybutynin Release and Absorption From Oxybutynin Products

A Early Phase 1 study testing oxybutynin in people with Heat Effect, run by University of Maryland, Baltimore at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This research study is intended to determine the effect of heat and occlusion on oxybutynin products. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Heat Effect
What is being tested?: oxybutynin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteUnited States
Study dates: 2 Jan 2018to 13 Nov 2019
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Men or non-pregnant, non-lactating women who are of any ethnic background between the age of 18 to 45 years old
Subjects must be non-smokers/tobacco users (must have refrained from the use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, snuff, gum, patches or electronic cigarettes) over the previous 2 months and are not currently using tobacco products
Provide written informed consent before initiation of any of the study procedures
Agree not to participate in another clinical trial/study or to participate in an investigational drug study for at least one month after the last study session
Able to adhere to the study restrictions and protocol schedule
Able to participate in all study sessions

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Subjects have upper arms large enough to allow for placement of 200 cm2 [31 in2] area for applications of gel. The arm distance from the greater tubercle to the olecranon process should be a minimum of 30 cm. The circumference of the upper arms should be a minimum of 30 cm.
Subjects deemed to be healthy as judged by the Medically Accountable Investigator (MAI) and determined by medical history, physical examination and medication history
Negative urine drug screening test (cannabinoids, amphetamines, barbiturates, benzodiazepine, cocaine, methadone, opiates, PCP)
Have normal screening laboratories for white blood cells (WBC), hemoglobin (Hgb), platelets, sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, alanine transaminase (ALT) and aspartate aminotransferase (AST)
Have normal screening laboratories for urine protein and urine glucose
Female subjects must be of non-childbearing potential (as defined as surgically sterile [i.e. history of hysterectomy or tubal ligation] or postmenopausal for more than 1 year), or if of childbearing potential must be non-pregnant at the time of enrollment and on the morning of each procedure day, and must agree to use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or a vasectomized partner
Agree not to donate blood to a blood bank throughout participation in the study and for at least three months after last procedure day
Have a normal ECG; must not have the following to be acceptable: pathologic Q wave abnormalities, significant ST-T wave changes, left ventricular hypertrophy, right bundle branch block, left bundle branch block. (sinus rhythm is between 55-100 beats per minute)
Have normal vital signs:
Temperature 35-37.9°C (95-100.3°F)
Systolic blood pressure 90-165 mmHg
Diastolic blood pressure 60-100 mmHg
Heart rate 55-100 beats per minute
Respiration rate 12-20 breaths per minute

Who cannot join

Women who are pregnant, lactating, breast feeding or have a positive serum pregnancy test at enrollment or positive urine pregnancy test on the morning of any study session
Smokers/tobacco users (current use or use over the previous 2 months of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, snuff, gum, patch or electronic cigarettes)
Participation in any ongoing investigational drug trial/study or clinical drug trial/study
History of chronic obstructive pulmonary disease or cor pulmonale, or substantially decreased respiratory reserve, hypoxia, hypercapnia or pre-existing respiratory depression
Active positive Hepatitis B, C and/or HIV serologies
Positive urine drug screening test

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Use of chronic prescription medications during the period 0 to 30 days; or over-the-counter medication (e.g. bisphosphonates [to treat osteoporosis], anticholinergics [used to treat diseases like asthma, incontinence, gastrointestinal cramps, and muscular spasms], antihistamines, topical corticosteroids) and short term (<30 days) prescription medications during the period 0-3 days before a study session [vitamin, herbal supplements and birth control medications not included)]
Donation or loss of greater than one pint of blood within 60 days of entry to the study
Any prior allergies to oxybutynin, other ingredients in the patch, gel or oral tablet tested, to medical tape products or other skin patches
Subject has problems with urinary retention, gastric retention or gastrointestinal obstruction
Subject has ulcerative colitis
Subject has gastric reflux disease or esophagitis
Subject has uncontrolled narrow-angle glaucoma
Subject has myasthenia gravis
Received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within one month before enrollment in this study or expects to receive an experimental agent during the study
Any condition that would, in the opinion of the Medically Accountable Investigator (MAI), place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
Consumption (food or drink) of alcohol within 24 h prior to dose administration
History as either reported by the subject or evident to the investigator of infectious disease or skin infection or of chronic skin disease (e.g., psoriasis, atopic dermatitis)
History of diabetes
Hereditary skin disorders or any skin inflammatory conditions as reported by the volunteer or evident to the MAI
History of significant dermatologic cancers (e.g., melanoma, squamous cell carcinoma) except basal cell carcinomas that were superficial and did not involve the investigative sites
Subject has an obvious difference in skin color between arms or the presence of a skin condition, excessive hair at the application site (upper arms), sunburn, raised moles and scars, open sores at application site (upper arms), scar tissue, tattoo, or coloration that would interfere with placement of products, skin assessment, or reactions to oxybutynin
BMI ≥30 kg/m2

Trial locations and contacts

1 site in 1 country.

United States1 site

General Clinical Research Center (GCRC) at the University of Maryland Medical Center
Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: Determination of Serum Oxybutynin Levels After Using Oxybutynin Transdermal Delivery System and Transdermal Gel With and Without Standardized Heat Application in Healthy Human Volunteers

This research study is intended to determine the effect of heat and occlusion on oxybutynin products.

Read the detailed description

This research study is intended to determine the effect of heat and occlusion on oxybutynin products. This study will use an oxybutynin patch and gel that have been approved by the Food and Drug Administration (FDA) and are already sold to customers in the United States; will not include any placebos.

Conditions: Heat Effect
Being tested: oxybutynin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

oxybutyninDrug
patch
oxybutyninDrug
gel

Study groups in NCT03205605
Study group	Role	What they receive
baseline patch	Other	patch Receives: Drug: oxybutynin
baseline gel	Other	gel Receives: Drug: oxybutynin
patch with heat	Other	patch Receives: Drug: oxybutynin
gel with occlusion	Other	gel Receives: Drug: oxybutynin

What is being measured

The primary outcome is the main question the study is designed to answer.

PK Parameter
Cmax (oxybutynin) during first heat period for patch (24-25.5 h)
Measured: 24 h, 24 h 15 min, 24 h 30 min, 24 h 45 min, 25 h, 25 h 15 min, 25 h 30 min post patch application
PK Parameter
Serum concentration (oxybutynin) at 30 h time point (patch removal)
Measured: 30 h post patch application
PK Parameter
Cmax (oxybutynin) at second heat exposure (30-31.5 h); after patch removed
Measured: 30 h, 30 h 15 min, 30 h 30 min (patch removed at 30 h)
PK Parameter
Cmax (oxybutynin)
Measured: 0 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 7 h 15 min, 7 h 30 min, 7 h 45 min, 8 h, 8 h 15 min, 8 h 30 min, 8 h 45 min, 9 h, 9 h 15 min, 9 h 30 min, 9 h 45 min, 10 h, 10 h 30 min, 11 h, 11 h 30 min, 12 h post gel application
PK Parameter
Cmax (N-desethyl oxybutynin)
Measured: 0 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 7 h 15 min, 7 h 30 min, 7 h 45 min, 8 h, 8 h 15 min, 8 h 30 min, 8 h 45 min, 9 h, 9 h 15 min, 9 h 30 min, 9 h 45 min, 10 h, 10 h 30 min, 11 h, 11 h 30 min, 12 h post gel application

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jan 201813 Nov 2019

First posted2 Jul 2017
Study start2 Jan 2018
Primary completion13 Nov 2019
Study completion13 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Heat EffectStudies of the same condition, open and under way.
More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
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: Early Phase 1
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03205605
Sponsor's protocol ID: HP-00070850
Status last verified: Mar 2022
First submitted: 26 Jun 2017
Last updated: 11 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruiting
Evaluation of Exercise With Overdressing to Induce Heat Acclimation in an Average Fitness Warfighter
Heat Acclimation and Thermotolerance
Not yet recruiting
Rapid Cool: Heat Stroke Treatment
Hyperthermia
Enrolling by invitation
Heat Application and Shoulder Pillow for Post-Laparoscopic Shoulder Pain
Laparoscopic Cholecystectomy, Shoulder Pain
Active, not recruiting
Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) For Prostate Cancer
Prostate Cancer

All Heat Effect trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Determination of Serum Oxybutynin Levels After Using Oxybutynin Transdermal Delivery System and Transdermal Gel With and Without Standardized Heat Application in Healthy Human Volunteers
ClinicalTrials.gov ID: NCT03205605
Acronym / sponsor ID: HP-00070850
Conditions: Heat Effect
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Collaborators: Food and Drug Administration (FDA)
Study start: 2 Jan 2018 (actual)
Primary completion: 13 Nov 2019 (actual)
Study completion: 13 Nov 2019 (actual)
First posted: 2 Jul 2017 (actual)
Results: Posted 14 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This research study is intended to determine the effect of heat and occlusion on oxybutynin products.

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
baseline patch	Other	Drug: oxybutyninpatch
baseline gel	Other	Drug: oxybutyningel
patch with heat	Other	Drug: oxybutyninpatch
gel with occlusion	Other	Drug: oxybutyningel

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (20 listed)

Men or non-pregnant, non-lactating women who are of any ethnic background between the age of 18 to 45 years old
Subjects must be non-smokers/tobacco users (must have refrained from the use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, snuff, gum, patches or electronic cigarettes) over the previous 2 months and are not currently using tobacco products
Provide written informed consent before initiation of any of the study procedures
Agree not to participate in another clinical trial/study or to participate in an investigational drug study for at least one month after the last study session
Able to adhere to the study restrictions and protocol schedule

Key exclusion criteria (23 listed)

Women who are pregnant, lactating, breast feeding or have a positive serum pregnancy test at enrollment or positive urine pregnancy test on the morning of any study session
Smokers/tobacco users (current use or use over the previous 2 months of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, snuff, gum, patch or electronic cigarettes)
Participation in any ongoing investigational drug trial/study or clinical drug trial/study
History of chronic obstructive pulmonary disease or cor pulmonale, or substantially decreased respiratory reserve, hypoxia, hypercapnia or pre-existing respiratory depression
Active positive Hepatitis B, C and/or HIV serologies

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
oxybutyninpatch	Drug	baseline patch, patch with heat
oxybutyningel	Drug	baseline gel, gel with occlusion

Primary outcome

PK Parameter
Time frame: 24 h, 24 h 15 min, 24 h 30 min, 24 h 45 min, 25 h, 25 h 15 min, 25 h 30 min post patch application
Cmax (oxybutynin) during first heat period for patch (24-25.5 h)
PK Parameter
Time frame: 30 h post patch application
Serum concentration (oxybutynin) at 30 h time point (patch removal)
PK Parameter
Time frame: 30 h, 30 h 15 min, 30 h 30 min (patch removed at 30 h)
Cmax (oxybutynin) at second heat exposure (30-31.5 h); after patch removed
PK Parameter
Time frame: 0 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 7 h 15 min, 7 h 30 min, 7 h 45 min, 8 h, 8 h 15 min, 8 h 30 min, 8 h 45 min, 9 h, 9 h 15 min, 9 h 30 min, 9 h 45 min, 10 h, 10 h 30 min, 11 h, 11 h 30 min, 12 h post gel application
Cmax (oxybutynin)
PK Parameter
Time frame: 0 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 7 h 15 min, 7 h 30 min, 7 h 45 min, 8 h, 8 h 15 min, 8 h 30 min, 8 h 45 min, 9 h, 9 h 15 min, 9 h 30 min, 9 h 45 min, 10 h, 10 h 30 min, 11 h, 11 h 30 min, 12 h post gel application
Cmax (N-desethyl oxybutynin)

Results and safety

Results posted to the registry on 14 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oxybutynin Patch and Gel	13	12

Primary outcome: PK Parameter

Time frame: 24 h, 24 h 15 min, 24 h 30 min, 24 h 45 min, 25 h, 25 h 15 min, 25 h 30 min post patch application. Mean (Standard Error). Unit: ng/mL

Measure	Oxytrol for Women Patch (Baseline) n = 13	Oxytrol for Women Patch (Heat Exposure) n = 12
Value	3.38 (0.63)	30.75 (20.31)

Primary outcome: PK Parameter

Time frame: 30 h post patch application. Mean (Standard Error). Unit: ng/mL

Measure	Oxytrol for Women Patch (Baseline) n = 13	Oxytrol for Women Patch (Heat Exposure) n = 12
Value	4.06 (1.24)	12.99 (10.02)

Primary outcome: PK Parameter

Time frame: 30 h, 30 h 15 min, 30 h 30 min (patch removed at 30 h). Mean (Standard Error). Unit: ng/mL

Measure	Oxytrol for Women Patch (Baseline) n = 13	Oxytrol for Women Patch (Heat Exposure) n = 12
Value	4.96 (1.19)	22.43 (15.14)

Primary outcome: PK Parameter

Time frame: 0 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 7 h 15 min, 7 h 30 min, 7 h 45 min, 8 h, 8 h 15 min, 8 h 30 min, 8 h 45 min, 9 h, 9 h 15 min, 9 h 30 min, 9 h 45 min, 10 h, 10 h 30 min, 11 h, 11 h 30 min, 12 h post gel application. Mean (Standard Error). Unit: ng/mL

Measure	Gelnique Gel (Baseline) n = 12	Gelnique Gel (Occlusion) n = 12
Value	5.00 (2.09)	71.93 (32.21)

Adverse events

Time frame: For Study Session 1 & 3, 34 h 30 min post initial patch application followed by up to 72 h phone follow up. For Study Session 2 & 4, 12 h during gel application followed by up to 72 h phone follow up. If there was an adverse event, volunteers were followed up until adverse event resolved.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Baseline Patch	0 of 13 (0%)	13 of 13 (100%)	0 of 13
Baseline Gel	0 of 13 (0%)	7 of 13 (53.8%)	0 of 13
Patch With Heat	0 of 12 (0%)	10 of 12 (83.3%)	0 of 12
Gel With Occlusion	0 of 12 (0%)	10 of 12 (83.3%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Heat Effect

Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruiting
Evaluation of Exercise With Overdressing to Induce Heat Acclimation in an Average Fitness Warfighter
Heat Acclimation and Thermotolerance
Not yet recruiting
Rapid Cool: Heat Stroke Treatment
Hyperthermia
Enrolling by invitation
Heat Application and Shoulder Pillow for Post-Laparoscopic Shoulder Pain
Laparoscopic Cholecystectomy, Shoulder Pain
Active, not recruiting
Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) For Prostate Cancer
Prostate Cancer

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.

Audra L Stinchcomb, PhD principal investigator

University of Maryland Baltimore School of Pharmacy

Hazem E Hassan, PhD principal investigator

University of Maryland Baltimore School of Pharmacy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing oxybutynin in people with Heat Effect, run by University of Maryland, Baltimore at 1 site in United States.

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 20 inclusion and 23 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: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

PK Parameter (time frame: 24 h, 24 h 15 min, 24 h 30 min, 24 h 45 min, 25 h, 25 h 15 min, 25 h 30 min post patch application). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03205605.

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 11 Apr 2022.