Trial Outcomes & Findings for Transdermal Patch CVD 1000: The Effect of Heat on Nicotine Release From Nicotine Patches in Adult Smokers (NCT NCT02371850)
NCT ID: NCT02371850
Last Updated: 2021-06-16
Results Overview
The main outcome measure of the study is the measurement of maximum serum concentration (Cmax)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
10 participants
Primary outcome timeframe
four procedure days for each participant
Results posted on
2021-06-16
Participant Flow
Participant milestones
| Measure |
Nicoderm Patch First, Then Aveva Patch
Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
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|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transdermal Patch CVD 1000: The Effect of Heat on Nicotine Release From Nicotine Patches in Adult Smokers
Baseline characteristics by cohort
| Measure |
Nicoderm Patch First, Then Aveva Patch
n=10 Participants
Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
29 years
STANDARD_DEVIATION 6.41 • n=93 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
|
Region of Enrollment
United States
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10 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: four procedure days for each participantPopulation: Ten adult smokers between 24 and 44 years of age at the time of enrollment completed the study. The clinical study was an single-group, open-label study. Each subject completed 4 study visits where in-vivo nicotine levels were measured using a reference patch (Nicoderm CQ) and a generic patch (Aveva)
The main outcome measure of the study is the measurement of maximum serum concentration (Cmax)
Outcome measures
| Measure |
Nicoderm Patch First, Then Aveva Patch
n=10 Participants
Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
|
NicoDerm CQ (Late Heat)
late heat
|
Aveva (Early Heat)
early heat
|
Aveva (Late Heat)
late heat
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|---|---|---|---|---|
|
Measurement of Maximum Serum Concentration (Cmax)
NicoDerm CQ early heat serum nicotine Cmax
|
27.47 ng/mL
Standard Deviation 10.49
|
—
|
—
|
—
|
|
Measurement of Maximum Serum Concentration (Cmax)
Aveva early heat serum nicotine Cmax
|
21.32 ng/mL
Standard Deviation 13.42
|
—
|
—
|
—
|
|
Measurement of Maximum Serum Concentration (Cmax)
NicoDerm CQ late heat serum nicotine Cmax
|
28.04 ng/mL
Standard Deviation 8.98
|
—
|
—
|
—
|
|
Measurement of Maximum Serum Concentration (Cmax)
Aveva late heat serum nicotine Cmax
|
22.96 ng/mL
Standard Deviation 9.55
|
—
|
—
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—
|
SECONDARY outcome
Timeframe: 0-12 h for each of the four procedure day(area under the concentration-time curve of nicotine 0-12 h)
Outcome measures
| Measure |
Nicoderm Patch First, Then Aveva Patch
n=10 Participants
Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
|
NicoDerm CQ (Late Heat)
n=10 Participants
late heat
|
Aveva (Early Heat)
n=10 Participants
early heat
|
Aveva (Late Heat)
n=10 Participants
late heat
|
|---|---|---|---|---|
|
AUC
|
173.8 h*ng/mL
Standard Deviation 54.10
|
184.3 h*ng/mL
Standard Deviation 67.92
|
116.3 h*ng/mL
Standard Deviation 73.41
|
121.20 h*ng/mL
Standard Deviation 49.98
|
Adverse Events
Nicoderm Patch 4 h Heat Application
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Nicoderm Patch 8 h Heat Application
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Aveva Patch 4 h Heat Application
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Aveva Patch 8 h Heat Application
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nicoderm Patch 4 h Heat Application
n=10 participants at risk
Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
|
Nicoderm Patch 8 h Heat Application
n=10 participants at risk
Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
|
Aveva Patch 4 h Heat Application
n=10 participants at risk
Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
|
Aveva Patch 8 h Heat Application
n=10 participants at risk
Each subjects gets two procedure days with heating applied for one hour at hours 4 and hour 8 after the application of the Nicoderm CQ nicotine patch, then followed by two procedure days with heating applied for one hour at hours 4 and hour 8, after the application of the Aveva nicotine patch (total of four Procedure days)
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|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema at the site of patch placement
|
10.0%
1/10 • Number of events 1 • 1 year
The definition does not differ.
|
30.0%
3/10 • Number of events 3 • 1 year
The definition does not differ.
|
10.0%
1/10 • Number of events 1 • 1 year
The definition does not differ.
|
10.0%
1/10 • Number of events 1 • 1 year
The definition does not differ.
|
|
Respiratory, thoracic and mediastinal disorders
Elevated Respiratory Rate
|
20.0%
2/10 • Number of events 2 • 1 year
The definition does not differ.
|
40.0%
4/10 • Number of events 4 • 1 year
The definition does not differ.
|
40.0%
4/10 • Number of events 5 • 1 year
The definition does not differ.
|
10.0%
1/10 • Number of events 1 • 1 year
The definition does not differ.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
0.00%
0/10 • 1 year
The definition does not differ.
|
10.0%
1/10 • Number of events 1 • 1 year
The definition does not differ.
|
0.00%
0/10 • 1 year
The definition does not differ.
|
0.00%
0/10 • 1 year
The definition does not differ.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/10 • 1 year
The definition does not differ.
|
0.00%
0/10 • 1 year
The definition does not differ.
|
20.0%
2/10 • Number of events 2 • 1 year
The definition does not differ.
|
0.00%
0/10 • 1 year
The definition does not differ.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/10 • 1 year
The definition does not differ.
|
0.00%
0/10 • 1 year
The definition does not differ.
|
10.0%
1/10 • Number of events 1 • 1 year
The definition does not differ.
|
0.00%
0/10 • 1 year
The definition does not differ.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Number of events 1 • 1 year
The definition does not differ.
|
0.00%
0/10 • 1 year
The definition does not differ.
|
0.00%
0/10 • 1 year
The definition does not differ.
|
0.00%
0/10 • 1 year
The definition does not differ.
|
|
General disorders
Headache
|
10.0%
1/10 • Number of events 1 • 1 year
The definition does not differ.
|
0.00%
0/10 • 1 year
The definition does not differ.
|
0.00%
0/10 • 1 year
The definition does not differ.
|
0.00%
0/10 • 1 year
The definition does not differ.
|
|
General disorders
Heat rash
|
10.0%
1/10 • Number of events 1 • 1 year
The definition does not differ.
|
0.00%
0/10 • 1 year
The definition does not differ.
|
0.00%
0/10 • 1 year
The definition does not differ.
|
0.00%
0/10 • 1 year
The definition does not differ.
|
|
General disorders
Numbness
|
0.00%
0/10 • 1 year
The definition does not differ.
|
0.00%
0/10 • 1 year
The definition does not differ.
|
0.00%
0/10 • 1 year
The definition does not differ.
|
10.0%
1/10 • Number of events 1 • 1 year
The definition does not differ.
|
|
General disorders
Skin redness
|
0.00%
0/10 • 1 year
The definition does not differ.
|
10.0%
1/10 • Number of events 1 • 1 year
The definition does not differ.
|
0.00%
0/10 • 1 year
The definition does not differ.
|
0.00%
0/10 • 1 year
The definition does not differ.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/10 • 1 year
The definition does not differ.
|
0.00%
0/10 • 1 year
The definition does not differ.
|
10.0%
1/10 • Number of events 1 • 1 year
The definition does not differ.
|
10.0%
1/10 • Number of events 1 • 1 year
The definition does not differ.
|
|
Cardiac disorders
Elevated systolic
|
10.0%
1/10 • Number of events 1 • 1 year
The definition does not differ.
|
0.00%
0/10 • 1 year
The definition does not differ.
|
10.0%
1/10 • Number of events 1 • 1 year
The definition does not differ.
|
0.00%
0/10 • 1 year
The definition does not differ.
|
Additional Information
Audra Stinchcomb, PharmD
University of Maryland School of Pharmacy
Phone: 410-706-2646
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Restricted until the manuscript is published in a peer-reviewed journal.
- Publication restrictions are in place
Restriction type: OTHER