Trial Outcomes & Findings for A Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers (NCT NCT01702519)
NCT ID: NCT01702519
Last Updated: 2015-03-20
Results Overview
Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample was determined by plasma concentration time profile of nicotine. Blood samples were drawn at the following time intervals: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after the application of the patch. Patch was then removed after the collection of 24 hour blood sample. AUC(0 -t) was based on the baseline adjusted nicotine plasma concentration data.
COMPLETED
PHASE1
40 participants
Baseline to 32 hours
2015-03-20
Participant Flow
Participants were recruited at a single clinical site in the US.
A total of 128 participants were screened, of which only 40 were randomized into the study. 71 participants did not meet the study eligibility criteria, 4 were lost to follow up, 6 withdrew consent while the remaining 7 were not randomized due to the other reason.
Participant milestones
| Measure |
Test Then Reference Patch
Participants first applied a test nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied reference nicotine patch containing Reference adhesive (21 mg) for additional 24 hours.
|
Reference Then Test Patch
Participants first applied the Reference nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied the Test nicotine patch containing reference adhesive (21 mg) for additional 24 hours.
|
|---|---|---|
|
Period 1
STARTED
|
20
|
20
|
|
Period 1
COMPLETED
|
20
|
20
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout Period
STARTED
|
20
|
20
|
|
Washout Period
COMPLETED
|
19
|
18
|
|
Washout Period
NOT COMPLETED
|
1
|
2
|
|
Period 2
STARTED
|
19
|
18
|
|
Period 2
COMPLETED
|
19
|
18
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Test Then Reference Patch
Participants first applied a test nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied reference nicotine patch containing Reference adhesive (21 mg) for additional 24 hours.
|
Reference Then Test Patch
Participants first applied the Reference nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied the Test nicotine patch containing reference adhesive (21 mg) for additional 24 hours.
|
|---|---|---|
|
Washout Period
Lost to Follow-up
|
1
|
0
|
|
Washout Period
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
A Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers
Baseline characteristics by cohort
| Measure |
Test Then Reference Patch
n=20 Participants
Participants first applied a test nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied reference nicotine patch containing Reference adhesive (21 mg) for additional 24 hours.
|
Reference Then Test Patch
n=20 Participants
Participants first applied the Reference nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied the Test nicotine patch containing reference adhesive (21 mg) for additional 24 hours.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.3 Years
STANDARD_DEVIATION 11.33 • n=5 Participants
|
31.4 Years
STANDARD_DEVIATION 11.59 • n=7 Participants
|
33.8 Years
STANDARD_DEVIATION 11.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 32 hoursPopulation: Per Protocol Population, which consisted of all randomized participants who took at least one dose of the study treatment, did not have any protocol deviation, and provided enough pharmacokinetic data as determined by the pharmacokineticist.
Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample was determined by plasma concentration time profile of nicotine. Blood samples were drawn at the following time intervals: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after the application of the patch. Patch was then removed after the collection of 24 hour blood sample. AUC(0 -t) was based on the baseline adjusted nicotine plasma concentration data.
Outcome measures
| Measure |
Test Patch
n=38 Participants
Participants were instructed to wear transdermal nicotine patch (21 mg) with test adhesive, for 24 hours.
|
Reference Patch
n=38 Participants
Participants were instructed to wear transdermal nicotine patch (21 mg) with the reference adhesive, for 24 hours.
|
|---|---|---|
|
Area Under the Curve From Time 0 to the Last Quantifiable Sample, AUC(0-t)
|
494.54 nanogram (ng)*hour (hr)/milliliter (mL)
Standard Deviation 115.075 • Interval 0.92 to 1.0
|
528.43 nanogram (ng)*hour (hr)/milliliter (mL)
Standard Deviation 129.762 • Interval 0.91 to 0.98
|
PRIMARY outcome
Timeframe: Baseline to 32 hoursPopulation: Per Protocol Population, which consisted of all randomized participants who took at least one dose of the study treatment, did not have any protocol deviation, and provided enough pharmacokinetic data as determined by the pharmacokineticist.
Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. Maximum plasma nicotine concentration was determined from plasma concentration time profiles. Blood samples were drawn at various time points: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after application the patch. Patch was then removed after the collection of 24 hour blood sample. Cmax was based on the baseline adjusted nicotine plasma concentration data.
Outcome measures
| Measure |
Test Patch
n=38 Participants
Participants were instructed to wear transdermal nicotine patch (21 mg) with test adhesive, for 24 hours.
|
Reference Patch
n=38 Participants
Participants were instructed to wear transdermal nicotine patch (21 mg) with the reference adhesive, for 24 hours.
|
|---|---|---|
|
Maximum Measured Plasma Concentration (Cmax)
|
22.31 ng/mL
Standard Deviation 4.986
|
23.50 ng/mL
Standard Deviation 5.917
|
SECONDARY outcome
Timeframe: Baseline to 32 hoursPopulation: Per Protocol Population, which consisted of all randomized participants who took at least one dose of the study treatment, did not have any protocol deviation, and provided enough pharmacokinetic data as determined by the pharmacokineticist.
Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. Area under the plasma nicotine concentration time curve from zero extrapolated to infinity was determined by plasma concentration time profile of nicotine. Blood samples drawn at various time points including: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after wearing the patch. Patch was then removed after the collection of 24 hour blood sample. AUC(0 -inf) was based on the baseline adjusted nicotine plasma concentration data.
Outcome measures
| Measure |
Test Patch
n=38 Participants
Participants were instructed to wear transdermal nicotine patch (21 mg) with test adhesive, for 24 hours.
|
Reference Patch
n=38 Participants
Participants were instructed to wear transdermal nicotine patch (21 mg) with the reference adhesive, for 24 hours.
|
|---|---|---|
|
Area Under the Concentration Time Curve Between Zero and Infinity, AUC (0-inf)
|
505.13 ng*h/mL
Standard Deviation 118.939
|
541.15 ng*h/mL
Standard Deviation 134.854
|
SECONDARY outcome
Timeframe: Baseline to 32 hoursPopulation: Per protocol population, which included all randomized participants who took at least one dose of the drug, did not have any protocol deviations and whose data was considered evaluable by the pharmacokineticist.
Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. Time to Maximum Plasma Concentration was determined from plasma concentration time profiles. Blood samples were drawn at various time points; immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after application of the patch. Patch was then removed after the collection of 24 hour blood sample. Tmax was based on the baseline adjusted nicotine plasma concentration data.
Outcome measures
| Measure |
Test Patch
n=38 Participants
Participants were instructed to wear transdermal nicotine patch (21 mg) with test adhesive, for 24 hours.
|
Reference Patch
n=38 Participants
Participants were instructed to wear transdermal nicotine patch (21 mg) with the reference adhesive, for 24 hours.
|
|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax)
|
10.00 hrs
Interval 0.5 to 24.0
|
17.99 hrs
Interval 2.0 to 24.0
|
SECONDARY outcome
Timeframe: Baseline to 32 hoursPopulation: Per-prorocol population, which included all randomized participants who received at least one dose of the study treatment, had no protocol violation, and whose data was considered evaluable by the pharmacokineticist.
Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. The elimination half-life of nicotine was determined by from plasma concentration time profiles. Blood samples were drawn at several time points: immediately pre-dose, and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after the application of the patch. Patch was then removed after the collection of 24 hour blood sample. Plasma half-life (t1/2) was based on the baseline adjusted nicotine plasma concentration data
Outcome measures
| Measure |
Test Patch
n=38 Participants
Participants were instructed to wear transdermal nicotine patch (21 mg) with test adhesive, for 24 hours.
|
Reference Patch
n=38 Participants
Participants were instructed to wear transdermal nicotine patch (21 mg) with the reference adhesive, for 24 hours.
|
|---|---|---|
|
Plasma Half-life (t1/2)
|
2.55 Hrs
Interval 2.0 to 3.5
|
2.59 Hrs
Interval 2.0 to 3.7
|
SECONDARY outcome
Timeframe: Baseline to 32 hoursPopulation: Per protocol population, which included all randomized participants who took at least one dose of the study medications, had no protocol violations, and whose data was considered evaluable by the pharmacokineticist.
Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. Elimination rate constant for nicotine was determined from plasma concentration time profiles. Blood samples were drawn at several time points: immediately pre-dose, and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours the application of the patch. Patch was then removed after the collection of 24 hour blood sample. Elimination rate constant for nicotine was based on the baseline adjusted nicotine plasma concentration data.
Outcome measures
| Measure |
Test Patch
n=38 Participants
Participants were instructed to wear transdermal nicotine patch (21 mg) with test adhesive, for 24 hours.
|
Reference Patch
n=38 Participants
Participants were instructed to wear transdermal nicotine patch (21 mg) with the reference adhesive, for 24 hours.
|
|---|---|---|
|
Rate of Elimination (Kel)
|
0.27 1/hr
Interval 0.2 to 0.3
|
0.27 1/hr
Interval 0.2 to 0.3
|
Adverse Events
Test Patch
Reference Patch
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Patch
n=38 participants at risk
Participants were instructed to wear transdermal nicotine patch with test adhesive, for 24 hours.
|
Reference Patch
n=39 participants at risk
Participants were instructed to wear transdermal nicotine patch with reference adhesive, for 24 hours
|
|---|---|---|
|
General disorders
Application Site Erythema
|
39.5%
15/38 • Number of events 15 • AEs were collected from the start of the smoking abstinence sequestration period and until five days following last administration of the study treatments
|
51.3%
20/39 • Number of events 20 • AEs were collected from the start of the smoking abstinence sequestration period and until five days following last administration of the study treatments
|
|
General disorders
Application Site Pruritus
|
13.2%
5/38 • Number of events 5 • AEs were collected from the start of the smoking abstinence sequestration period and until five days following last administration of the study treatments
|
17.9%
7/39 • Number of events 7 • AEs were collected from the start of the smoking abstinence sequestration period and until five days following last administration of the study treatments
|
|
Nervous system disorders
Headache
|
5.3%
2/38 • Number of events 2 • AEs were collected from the start of the smoking abstinence sequestration period and until five days following last administration of the study treatments
|
10.3%
4/39 • Number of events 4 • AEs were collected from the start of the smoking abstinence sequestration period and until five days following last administration of the study treatments
|
|
Psychiatric disorders
Abnormal Dreams
|
0.00%
0/38 • AEs were collected from the start of the smoking abstinence sequestration period and until five days following last administration of the study treatments
|
10.3%
4/39 • Number of events 4 • AEs were collected from the start of the smoking abstinence sequestration period and until five days following last administration of the study treatments
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER