Trial Outcomes & Findings for Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product. (NCT NCT01084707)
NCT ID: NCT01084707
Last Updated: 2012-07-13
Results Overview
Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
During the last dosing interval (hour 11-12 post-dose)
Results posted on
2012-07-13
Participant Flow
This was a five-arm cross-over trial, with subjects randomized to the order they received the different treatments and with analysis performed on valid pharmacokinetic data. Therefore, Number of Participants Analyzed in each arm represents the same subjects, and the total is not consistent with numbers provided in the participant flow module.
Participant milestones
| Measure |
Overall Study
All subjects randomized into the trial
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Overall Study
All subjects randomized into the trial
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
Baseline Characteristics
Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.
Baseline characteristics by cohort
| Measure |
All Randomized Subjects
n=40 Participants
All subjects randomized into the trial, e.g., Full Analysis Set
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the last dosing interval (hour 11-12 post-dose)Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)
Outcome measures
| Measure |
Oral Nicotine 24-SA
n=39 Participants
Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
|
Oral Nicotine 24
n=35 Participants
Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
|
Oral Nicotine 48
n=32 Participants
Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
|
NiQuitin™ Lozenge 4 mg
n=35 Participants
NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
|
Nicorette® Gum 4 mg
n=32 Participants
12 doses of NICORETTE® gum 4 mg over 11 hours
|
|---|---|---|---|---|---|
|
Maximum Plasma Concentration
|
15.43 (ng/ml)
Standard Deviation 6.12
|
16.49 (ng/ml)
Standard Deviation 4.99
|
30.07 (ng/ml)
Standard Deviation 9.77
|
27.07 (ng/ml)
Standard Deviation 10.95
|
25.96 (ng/ml)
Standard Deviation 8.55
|
PRIMARY outcome
Timeframe: During the last dosing interval (hour 11-12 post-dose)Population: ITT
Pharmacokinetic measurement - average concentration during the last dosing interval (AUCtau)
Outcome measures
| Measure |
Oral Nicotine 24-SA
n=39 Participants
Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
|
Oral Nicotine 24
n=35 Participants
Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
|
Oral Nicotine 48
n=32 Participants
Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
|
NiQuitin™ Lozenge 4 mg
n=35 Participants
NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
|
Nicorette® Gum 4 mg
n=32 Participants
12 doses of NICORETTE® gum 4 mg over 11 hours
|
|---|---|---|---|---|---|
|
Average Concentration
|
13.33 (ng/ml)
Standard Deviation 5.55
|
14.04 (ng/ml)
Standard Deviation 4.50
|
27.50 (ng/ml)
Standard Deviation 9.18
|
23.70 (ng/ml)
Standard Deviation 9.86
|
22.15 (ng/ml)
Standard Deviation 7.49
|
SECONDARY outcome
Timeframe: During the last dosing interval (hour 11-12 post-dose)Population: ITT
The time at which maximum concentration is reached (Tmax)
Outcome measures
| Measure |
Oral Nicotine 24-SA
n=39 Participants
Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
|
Oral Nicotine 24
n=35 Participants
Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
|
Oral Nicotine 48
n=32 Participants
Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
|
NiQuitin™ Lozenge 4 mg
n=35 Participants
NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
|
Nicorette® Gum 4 mg
n=32 Participants
12 doses of NICORETTE® gum 4 mg over 11 hours
|
|---|---|---|---|---|---|
|
Time of Maximum Concentration
|
15.0 (minutes)
Full Range 9.0 • Interval 5.0 to 42.0
|
10.0 (minutes)
Full Range 9.2 • Interval 5.0 to 45.0
|
10.0 (minutes)
Full Range 5.3 • Interval 5.0 to 23.0
|
25.0 (minutes)
Full Range 10.4 • Interval 13.0 to 55.0
|
30.0 (minutes)
Full Range 9.1 • Interval 10.0 to 50.0
|
SECONDARY outcome
Timeframe: During the last dosing interval (hour 11-12 post-dose)Population: ITT
The minimum nicotine plasma concentration during the last dosing interval (Cmin)
Outcome measures
| Measure |
Oral Nicotine 24-SA
n=39 Participants
Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
|
Oral Nicotine 24
n=35 Participants
Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
|
Oral Nicotine 48
n=32 Participants
Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
|
NiQuitin™ Lozenge 4 mg
n=35 Participants
NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
|
Nicorette® Gum 4 mg
n=32 Participants
12 doses of NICORETTE® gum 4 mg over 11 hours
|
|---|---|---|---|---|---|
|
Minimum Plasma Concentration
|
11.54 (ng/ml)
Standard Deviation 4.71
|
11.67 (ng/ml)
Standard Deviation 4.04
|
25.32 (ng/ml)
Standard Deviation 8.41
|
22.14 (ng/ml)
Standard Deviation 9.71
|
19.00 (ng/ml)
Standard Deviation 7.00
|
SECONDARY outcome
Timeframe: During the last dosing interval (hour 11-12 post-dose)Population: ITT
Percent of peak-trough fluctuation over one dosing interval at steady state (PTF)
Outcome measures
| Measure |
Oral Nicotine 24-SA
n=39 Participants
Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
|
Oral Nicotine 24
n=35 Participants
Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
|
Oral Nicotine 48
n=32 Participants
Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
|
NiQuitin™ Lozenge 4 mg
n=35 Participants
NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
|
Nicorette® Gum 4 mg
n=32 Participants
12 doses of NICORETTE® gum 4 mg over 11 hours
|
|---|---|---|---|---|---|
|
Peak-Trough Fluctuation
|
35.6 Percent Fluctuation
Standard Deviation 14.2
|
38.4 Percent Fluctuation
Standard Deviation 14.9
|
21.7 Percent Fluctuation
Standard Deviation 8.7
|
29.1 Percent Fluctuation
Standard Deviation 10.7
|
36.3 Percent Fluctuation
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: One hour after start of treatmentPopulation: ITT
The nicotine concentration in plasma (area under the nicotine plasma concentration curve) 1 hour after start of treatment
Outcome measures
| Measure |
Oral Nicotine 24-SA
n=36 Participants
Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
|
Oral Nicotine 24
n=34 Participants
Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
|
Oral Nicotine 48
Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
|
NiQuitin™ Lozenge 4 mg
NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
|
Nicorette® Gum 4 mg
12 doses of NICORETTE® gum 4 mg over 11 hours
|
|---|---|---|---|---|---|
|
Nicotine Plasma Concentration
|
4.49 (ng/ml)
Standard Deviation 1.60
|
4.76 (ng/ml)
Standard Deviation 1.45
|
—
|
—
|
—
|
Adverse Events
Oral Nicotine 24-SA
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Oral Nicotine 24
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Oral Nicotine 48
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
NiQuitin™ Lozenge 4 mg
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Nicorette® Gum 4 mg
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oral Nicotine 24-SA
n=40 participants at risk
Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
|
Oral Nicotine 24
n=37 participants at risk
Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
|
Oral Nicotine 48
n=36 participants at risk
Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
|
NiQuitin™ Lozenge 4 mg
n=35 participants at risk
NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
|
Nicorette® Gum 4 mg
n=35 participants at risk
12 doses of NICORETTE® gum 4 mg over 11 hours
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/40
|
2.7%
1/37
|
19.4%
7/36
|
0.00%
0/35
|
14.3%
5/35
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.5%
3/40
|
2.7%
1/37
|
11.1%
4/36
|
20.0%
7/35
|
17.1%
6/35
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
2/40
|
5.4%
2/37
|
2.8%
1/36
|
5.7%
2/35
|
8.6%
3/35
|
|
Gastrointestinal disorders
Eructation
|
5.0%
2/40
|
5.4%
2/37
|
2.8%
1/36
|
2.9%
1/35
|
17.1%
6/35
|
|
Gastrointestinal disorders
Nausea
|
12.5%
5/40
|
8.1%
3/37
|
11.1%
4/36
|
11.4%
4/35
|
11.4%
4/35
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
17.5%
7/40
|
0.00%
0/37
|
2.8%
1/36
|
0.00%
0/35
|
8.6%
3/35
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
2/40
|
5.4%
2/37
|
8.3%
3/36
|
8.6%
3/35
|
0.00%
0/35
|
|
Nervous system disorders
Headache
|
25.0%
10/40
|
16.2%
6/37
|
27.8%
10/36
|
20.0%
7/35
|
20.0%
7/35
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
45.0%
18/40
|
48.6%
18/37
|
50.0%
18/36
|
25.7%
9/35
|
17.1%
6/35
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/40
|
0.00%
0/37
|
2.8%
1/36
|
5.7%
2/35
|
8.6%
3/35
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
7.5%
3/40
|
0.00%
0/37
|
0.00%
0/36
|
0.00%
0/35
|
8.6%
3/35
|
|
Gastrointestinal disorders
Lacrimation Increase
|
0.00%
0/40
|
5.4%
2/37
|
2.8%
1/36
|
0.00%
0/35
|
0.00%
0/35
|
|
Gastrointestinal disorders
Diarrheoa
|
2.5%
1/40
|
2.7%
1/37
|
2.8%
1/36
|
2.9%
1/35
|
5.7%
2/35
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/40
|
0.00%
0/37
|
0.00%
0/36
|
5.7%
2/35
|
2.9%
1/35
|
|
Gastrointestinal disorders
Glossodynia
|
5.0%
2/40
|
5.4%
2/37
|
2.8%
1/36
|
0.00%
0/35
|
0.00%
0/35
|
|
Nervous system disorders
Dizziness
|
5.0%
2/40
|
0.00%
0/37
|
2.8%
1/36
|
5.7%
2/35
|
0.00%
0/35
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/40
|
0.00%
0/37
|
5.6%
2/36
|
0.00%
0/35
|
0.00%
0/35
|
|
Gastrointestinal disorders
Oropharyngial Pain
|
0.00%
0/40
|
0.00%
0/37
|
0.00%
0/36
|
5.7%
2/35
|
0.00%
0/35
|
Additional Information
Joyce Hauze, Sr. Specialist, Clinical Research Operations
J&J Consumer and Personal Products Worldwide
Phone: 928-277-0715
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place