Trial Outcomes & Findings for Effect of Heat on Oxybutynin Release and Absorption From Oxybutynin Products (NCT NCT03205605)
NCT ID: NCT03205605
Last Updated: 2022-04-11
Results Overview
Cmax (oxybutynin) during first heat period for patch (24-25.5 h)
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
13 participants
Primary outcome timeframe
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
Results posted on
2022-04-11
Participant Flow
Participant milestones
| Measure |
Oxybutynin Patch and Gel
First study session received one oxybutynin patch (Oxytrol for Women), then at least one week washout period Second study session received oxybutynin gel (Gelnique), then at least one week washout period Third study session received one oxybutynin patch (Oxytrol for Women) with early and late heat (90 minutes) exposure, then at least one week washout period Fourth study session received oxybutynin gel (Gelnique) with occlusion (3 hours)
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Oxybutynin Patch and Gel
First study session received one oxybutynin patch (Oxytrol for Women), then at least one week washout period Second study session received oxybutynin gel (Gelnique), then at least one week washout period Third study session received one oxybutynin patch (Oxytrol for Women) with early and late heat (90 minutes) exposure, then at least one week washout period Fourth study session received oxybutynin gel (Gelnique) with occlusion (3 hours)
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Effect of Heat on Oxybutynin Release and Absorption From Oxybutynin Products
Baseline characteristics by cohort
| Measure |
Oxybutynin Patch and Gel
n=13 Participants
First study session received one oxybutynin patch (Oxytrol for Women), then at least one week washout period Second study session received oxybutynin gel (Gelnique), then at least one week washout period Third study session received one oxybutynin patch (Oxytrol for Women) with early and late heat (90 minutes) exposure, then at least one week washout period Fourth study session received oxybutynin gel (Gelnique) with occlusion (3 hours)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34.08 years
STANDARD_DEVIATION 8.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 applicationCmax (oxybutynin) during first heat period for patch (24-25.5 h)
Outcome measures
| Measure |
Oxytrol for Women Patch (Baseline)
n=13 Participants
baseline (no heat exposure)
|
Oxytrol for Women Patch (Heat Exposure)
n=12 Participants
external heat exposure at 24-25.5 h and 30-31.5 h
|
|---|---|---|
|
PK Parameter
|
3.38 ng/mL
Standard Error 0.63
|
30.75 ng/mL
Standard Error 20.31
|
PRIMARY outcome
Timeframe: 30 h post patch applicationSerum concentration (oxybutynin) at 30 h time point (patch removal)
Outcome measures
| Measure |
Oxytrol for Women Patch (Baseline)
n=13 Participants
baseline (no heat exposure)
|
Oxytrol for Women Patch (Heat Exposure)
n=12 Participants
external heat exposure at 24-25.5 h and 30-31.5 h
|
|---|---|---|
|
PK Parameter
|
4.06 ng/mL
Standard Error 1.24
|
12.99 ng/mL
Standard Error 10.02
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Oxytrol for Women Patch (Baseline)
n=13 Participants
baseline (no heat exposure)
|
Oxytrol for Women Patch (Heat Exposure)
n=12 Participants
external heat exposure at 24-25.5 h and 30-31.5 h
|
|---|---|---|
|
PK Parameter
|
4.96 ng/mL
Standard Error 1.19
|
22.43 ng/mL
Standard Error 15.14
|
PRIMARY outcome
Timeframe: 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 applicationCmax (oxybutynin)
Outcome measures
| Measure |
Oxytrol for Women Patch (Baseline)
n=12 Participants
baseline (no heat exposure)
|
Oxytrol for Women Patch (Heat Exposure)
n=12 Participants
external heat exposure at 24-25.5 h and 30-31.5 h
|
|---|---|---|
|
PK Parameter
|
5.00 ng/mL
Standard Error 2.09
|
71.93 ng/mL
Standard Error 32.21
|
PRIMARY outcome
Timeframe: 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 applicationCmax (N-desethyl oxybutynin)
Outcome measures
| Measure |
Oxytrol for Women Patch (Baseline)
n=12 Participants
baseline (no heat exposure)
|
Oxytrol for Women Patch (Heat Exposure)
n=12 Participants
external heat exposure at 24-25.5 h and 30-31.5 h
|
|---|---|---|
|
PK Parameter
|
0.36 ng/mL
Standard Error 0.09
|
2.38 ng/mL
Standard Error 0.62
|
Adverse Events
Baseline Patch
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Baseline Gel
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Patch With Heat
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Gel With Occlusion
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Baseline Patch
n=13 participants at risk
patch
oxybutynin: patch
|
Baseline Gel
n=13 participants at risk
gel
oxybutynin: gel
|
Patch With Heat
n=12 participants at risk
patch
oxybutynin: patch
|
Gel With Occlusion
n=12 participants at risk
gel
oxybutynin: gel
|
|---|---|---|---|---|
|
Surgical and medical procedures
Pain at IV site
|
0.00%
0/13 • 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.
|
15.4%
2/13 • Number of events 2 • 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.
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
|
Skin and subcutaneous tissue disorders
vesicle (blister)
|
0.00%
0/13 • 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.
|
0.00%
0/13 • 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.
|
8.3%
1/12 • Number of events 1 • 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.
|
8.3%
1/12 • Number of events 2 • 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.
|
|
Blood and lymphatic system disorders
Hematoma
|
0.00%
0/13 • 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.
|
7.7%
1/13 • Number of events 1 • 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.
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
|
Gastrointestinal disorders
Constipation
|
15.4%
2/13 • Number of events 2 • 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.
|
0.00%
0/13 • 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.
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
|
General disorders
Headache
|
7.7%
1/13 • Number of events 1 • 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.
|
0.00%
0/13 • 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.
|
0.00%
0/12 • 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.
|
0.00%
0/12 • 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.
|
|
Cardiac disorders
Decreased heart rate
|
7.7%
1/13 • Number of events 1 • 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.
|
0.00%
0/13 • 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.
|
0.00%
0/12 • 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.
|
16.7%
2/12 • Number of events 2 • 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.
|
|
Cardiac disorders
Decreased blood pressure
|
7.7%
1/13 • Number of events 1 • 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.
|
15.4%
2/13 • Number of events 2 • 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.
|
8.3%
1/12 • Number of events 1 • 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.
|
25.0%
3/12 • Number of events 3 • 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.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA (skin reddening)
|
84.6%
11/13 • Number of events 11 • 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.
|
53.8%
7/13 • Number of events 7 • 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.
|
83.3%
10/12 • Number of events 10 • 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.
|
83.3%
10/12 • Number of events 15 • 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.
|
Additional Information
Dr. Audra Stinchcomb
University of Maryland, Baltimore School of Pharmacy
Phone: 410-706-2646
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place