Trial Outcomes & Findings for Scopolamine Patch Pharmacokinetics in Healthy Adults (NCT NCT03029650)
NCT ID: NCT03029650
Last Updated: 2018-06-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
26 participants
Primary outcome timeframe
Measured at time points: pre-dose, 1,2,3,4,5,6,8,10,12,24,36,48,60, and 72 hours during Intervention: Transderm Scop® and at time points: pre-dose, 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12 hours during Intervention: scopolamine HBr
Results posted on
2018-06-21
Participant Flow
Recruitment was conducted at the University of Iowa by advertisements in the "Noon News", a UIHC newsletter, and by a mass email that was sent to all staff/faculty/and students. Recruitment began in November 2016 and continued until the enrollment goal of 24 participants completing all arms of the study was reached in March 2017.
Participant milestones
| Measure |
Transderm Scop®, Then IV Scopolamine Hydrbromide
Participants wore a Transderm Scop® patch (1.5 mg) for 3 days and received a single intravenous dose of 0.4 mg scopolamine hydrobromide in a crossover design with adequate washout in between.
|
IV Scopolamine HBr, Then Transderm Scop®
Participants received a single intravenous dose of 0.4 mg scopolamine hydrobromide and will wore a Transderm Scop® patch (1.5 mg) for 3 days in a crossover design with adequate washout in between.
|
|---|---|---|
|
First Intervention (3 - 6 Days)
STARTED
|
14
|
12
|
|
First Intervention (3 - 6 Days)
COMPLETED
|
14
|
12
|
|
First Intervention (3 - 6 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout (1 Week)
STARTED
|
14
|
12
|
|
Washout (1 Week)
COMPLETED
|
13
|
10
|
|
Washout (1 Week)
NOT COMPLETED
|
1
|
2
|
|
2nd Intervention (3 - 6 Days)
STARTED
|
13
|
10
|
|
2nd Intervention (3 - 6 Days)
COMPLETED
|
13
|
10
|
|
2nd Intervention (3 - 6 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Transderm Scop®, Then IV Scopolamine Hydrbromide
Participants wore a Transderm Scop® patch (1.5 mg) for 3 days and received a single intravenous dose of 0.4 mg scopolamine hydrobromide in a crossover design with adequate washout in between.
|
IV Scopolamine HBr, Then Transderm Scop®
Participants received a single intravenous dose of 0.4 mg scopolamine hydrobromide and will wore a Transderm Scop® patch (1.5 mg) for 3 days in a crossover design with adequate washout in between.
|
|---|---|---|
|
Washout (1 Week)
Withdrawal by Subject
|
1
|
1
|
|
Washout (1 Week)
Physician Decision
|
0
|
1
|
Baseline Characteristics
Scopolamine Patch Pharmacokinetics in Healthy Adults
Baseline characteristics by cohort
| Measure |
All Study Participants
n=26 Participants
Each of the subjects received Transderm Scop® (1.5mg/72 hrs) and intravenous scopolamine hydrobromide (0.4 mg)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
|
Age, Continuous
|
24.32 years
STANDARD_DEVIATION 6.32 • n=39 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Caucasian/White
|
21 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
African American/Black
|
2 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Bi-/Multiracial
|
1 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Other/Chose not to answer
|
1 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=39 Participants
|
|
Body Mass Index
|
23.3 kg/m^2
STANDARD_DEVIATION 2.88 • n=39 Participants
|
PRIMARY outcome
Timeframe: Measured at time points: pre-dose, 1,2,3,4,5,6,8,10,12,24,36,48,60, and 72 hours during Intervention: Transderm Scop® and at time points: pre-dose, 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12 hours during Intervention: scopolamine HBrPopulation: The number of participants analyzed represents the total number of participants that completed both interventions.
Outcome measures
| Measure |
Transderm Scop®
n=23 Participants
All participants that received the Transderm Scop® (1.5mg/72 hrs) regardless of assigned arm
|
Intravenous Scopolamine Hydrobromide
n=23 Participants
All participants that received the intravenous scopolamine hydrobromide injection (0.4 mg) regardless of assigned arm
|
|---|---|---|
|
Measurement of Maximum Serum Concentration of Scopolamine (Cmax)
|
0.14 ng/ml
Standard Deviation 0.08
|
2.63 ng/ml
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: Measured at time points: 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12,24,36,48 hours during Intervention: scopolamine HBrThis will be done only after the IV is administered to estimate the rate of removal of scopolamine from the body. Will not be measured during patch arm.
Outcome measures
| Measure |
Transderm Scop®
n=23 Participants
All participants that received the Transderm Scop® (1.5mg/72 hrs) regardless of assigned arm
|
Intravenous Scopolamine Hydrobromide
All participants that received the intravenous scopolamine hydrobromide injection (0.4 mg) regardless of assigned arm
|
|---|---|---|
|
Assessment of Scopolamine Clearance (CL)
|
164.4 L/hr
Standard Deviation 48.8
|
—
|
SECONDARY outcome
Timeframe: Measured at time points: 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12,24,36,48 hours during Intervention: scopolamine HBrThis measure is only analyzed for the IV scopolamine HBr arm of the study.
Outcome measures
| Measure |
Transderm Scop®
n=23 Participants
All participants that received the Transderm Scop® (1.5mg/72 hrs) regardless of assigned arm
|
Intravenous Scopolamine Hydrobromide
All participants that received the intravenous scopolamine hydrobromide injection (0.4 mg) regardless of assigned arm
|
|---|---|---|
|
Measurement of Volume of Scopolamine Distribution (V)
|
488.3 L
Standard Deviation 191.2
|
—
|
SECONDARY outcome
Timeframe: Measured at time points: 73,74,78,84,96,108,120 hours during Intervention: Transderm Scop® and at time points: pre-dose, 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12 hours during Intervention: scopolamine HBrOutcome measures
| Measure |
Transderm Scop®
n=23 Participants
All participants that received the Transderm Scop® (1.5mg/72 hrs) regardless of assigned arm
|
Intravenous Scopolamine Hydrobromide
n=23 Participants
All participants that received the intravenous scopolamine hydrobromide injection (0.4 mg) regardless of assigned arm
|
|---|---|---|
|
Measurement of Elimination Rate Constant of Scopolamine (Kel)
|
0.06 1/hr
Standard Deviation 0.02
|
0.23 1/hr
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: Measured at time points: pre-dose, 1,2,3,4,5,6,8,10,12,24,36,48,60, and 72 hours during Intervention: Transderm Scop® and at time points: pre-dose, 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12 hours during Intervention: scopolamine HBrOutcome measures
| Measure |
Transderm Scop®
n=23 Participants
All participants that received the Transderm Scop® (1.5mg/72 hrs) regardless of assigned arm
|
Intravenous Scopolamine Hydrobromide
n=23 Participants
All participants that received the intravenous scopolamine hydrobromide injection (0.4 mg) regardless of assigned arm
|
|---|---|---|
|
Measurement of Time of Maximum Serum Scopolamine Concentration (Tmax)
|
9.65 hr
Standard Deviation 2.21
|
0.04 hr
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: Measured at time points:1,2,3,4,5,6,8,10,12,24,36,48,60,72,73,74,78,84,96,108,120 hours during Intervention: Transderm Scop® and at time points: 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12,24,36, and 48 hours during Intervention: scopolamine HBrOutcome measures
| Measure |
Transderm Scop®
n=23 Participants
All participants that received the Transderm Scop® (1.5mg/72 hrs) regardless of assigned arm
|
Intravenous Scopolamine Hydrobromide
n=23 Participants
All participants that received the intravenous scopolamine hydrobromide injection (0.4 mg) regardless of assigned arm
|
|---|---|---|
|
Determination of Area Under the Serum Concentration-time Curve (AUC)
|
8.01 ng*hr/ml
Standard Deviation 2.8
|
2.6 ng*hr/ml
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 3 - 6 monthsThis will be done in the TDDS after its removal to estimate total amount of absorbed scopolamine.
Outcome measures
| Measure |
Transderm Scop®
n=24 Participants
All participants that received the Transderm Scop® (1.5mg/72 hrs) regardless of assigned arm
|
Intravenous Scopolamine Hydrobromide
All participants that received the intravenous scopolamine hydrobromide injection (0.4 mg) regardless of assigned arm
|
|---|---|---|
|
Residual Drug Analysis in Worn TDDS
|
34.4 % residual drug recovery
Standard Deviation 7.7
|
—
|
Adverse Events
Intervention: Transderm Scop® (6 Days)
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Intervention: Intravenous Scopolamine Hydrobromide (3 Days)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention: Transderm Scop® (6 Days)
n=24 participants at risk
Transderm Scop® patch (1.5 mg) for 3 days with 3 days of follow up sample collection time points
Transderm Scop®: TDDS dosage is 1.5 mg/72 hrs
|
Intervention: Intravenous Scopolamine Hydrobromide (3 Days)
n=25 participants at risk
0.4 mg of intravenous scopolamine hydrobromide
Intravenous scopolamine hydrobromide: 0.4 mg via intravenous injection
|
|---|---|---|
|
General disorders
Decreased Blood Pressure
|
41.7%
10/24 • Number of events 15 • Adverse event data was collected in real time as subjects participated in the study. The study was completed in 5 months.
|
52.0%
13/25 • Number of events 37 • Adverse event data was collected in real time as subjects participated in the study. The study was completed in 5 months.
|
|
General disorders
Increased Blood Pressure
|
16.7%
4/24 • Number of events 7 • Adverse event data was collected in real time as subjects participated in the study. The study was completed in 5 months.
|
24.0%
6/25 • Number of events 8 • Adverse event data was collected in real time as subjects participated in the study. The study was completed in 5 months.
|
|
General disorders
Decreased Heart Rate
|
45.8%
11/24 • Number of events 63 • Adverse event data was collected in real time as subjects participated in the study. The study was completed in 5 months.
|
60.0%
15/25 • Number of events 73 • Adverse event data was collected in real time as subjects participated in the study. The study was completed in 5 months.
|
|
General disorders
Increased Heart Rate
|
4.2%
1/24 • Number of events 5 • Adverse event data was collected in real time as subjects participated in the study. The study was completed in 5 months.
|
8.0%
2/25 • Number of events 3 • Adverse event data was collected in real time as subjects participated in the study. The study was completed in 5 months.
|
|
General disorders
Dry Mouth
|
58.3%
14/24 • Number of events 31 • Adverse event data was collected in real time as subjects participated in the study. The study was completed in 5 months.
|
16.0%
4/25 • Number of events 10 • Adverse event data was collected in real time as subjects participated in the study. The study was completed in 5 months.
|
|
General disorders
Headache
|
8.3%
2/24 • Number of events 2 • Adverse event data was collected in real time as subjects participated in the study. The study was completed in 5 months.
|
12.0%
3/25 • Number of events 7 • Adverse event data was collected in real time as subjects participated in the study. The study was completed in 5 months.
|
|
General disorders
Dilated Pupils
|
8.3%
2/24 • Number of events 2 • Adverse event data was collected in real time as subjects participated in the study. The study was completed in 5 months.
|
24.0%
6/25 • Number of events 6 • Adverse event data was collected in real time as subjects participated in the study. The study was completed in 5 months.
|
|
General disorders
Nausea
|
8.3%
2/24 • Number of events 2 • Adverse event data was collected in real time as subjects participated in the study. The study was completed in 5 months.
|
16.0%
4/25 • Number of events 10 • Adverse event data was collected in real time as subjects participated in the study. The study was completed in 5 months.
|
|
General disorders
Emesis
|
0.00%
0/24 • Adverse event data was collected in real time as subjects participated in the study. The study was completed in 5 months.
|
12.0%
3/25 • Number of events 3 • Adverse event data was collected in real time as subjects participated in the study. The study was completed in 5 months.
|
|
General disorders
Dizziness
|
12.5%
3/24 • Number of events 5 • Adverse event data was collected in real time as subjects participated in the study. The study was completed in 5 months.
|
72.0%
18/25 • Number of events 62 • Adverse event data was collected in real time as subjects participated in the study. The study was completed in 5 months.
|
|
General disorders
Blurry Vision
|
33.3%
8/24 • Number of events 36 • Adverse event data was collected in real time as subjects participated in the study. The study was completed in 5 months.
|
12.0%
3/25 • Number of events 7 • Adverse event data was collected in real time as subjects participated in the study. The study was completed in 5 months.
|
|
General disorders
Fatigue
|
20.8%
5/24 • Number of events 9 • Adverse event data was collected in real time as subjects participated in the study. The study was completed in 5 months.
|
56.0%
14/25 • Number of events 41 • Adverse event data was collected in real time as subjects participated in the study. The study was completed in 5 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place