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Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.

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ClinicalTrials.gov Identifier: NCT01084707
Recruitment Status : Completed
First Posted : March 10, 2010
Results First Posted : October 19, 2010
Last Update Posted : July 13, 2012
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tobacco Dependence
Interventions Drug: Oral Nicotine
Drug: Nicotine Lozenge
Drug: Nicotine gum
Enrollment 40
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Overall Study
Hide Arm/Group Description All subjects randomized into the trial
Period Title: Overall Study
Started 40
Completed 34
Not Completed 6
Reason Not Completed
Withdrawal by Subject             6
Arm/Group Title All Randomized Subjects
Hide Arm/Group Description All subjects randomized into the trial, e.g., Full Analysis Set
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
<=18 years
0
   0.0%
Between 18 and 65 years
40
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
18
  45.0%
Male
22
  55.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Sweden Number Analyzed 40 participants
40
1.Primary Outcome
Title Maximum Plasma Concentration
Hide Description 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)
Time Frame During the last dosing interval (hour 11-12 post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Nicotine 24-SA Oral Nicotine 24 Oral Nicotine 48 NiQuitin™ Lozenge 4 mg Nicorette® Gum 4 mg
Hide Arm/Group Description:
Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
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; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
12 doses of NICORETTE® gum 4 mg over 11 hours
Overall Number of Participants Analyzed 39 35 32 35 32
Geometric Mean (Standard Deviation)
Unit of Measure: (ng/ml)
15.43  (6.12) 16.49  (4.99) 30.07  (9.77) 27.07  (10.95) 25.96  (8.55)
2.Primary Outcome
Title Average Concentration
Hide Description Pharmacokinetic measurement - average concentration during the last dosing interval (AUCtau)
Time Frame During the last dosing interval (hour 11-12 post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Oral Nicotine 24-SA Oral Nicotine 24 Oral Nicotine 48 NiQuitin™ Lozenge 4 mg Nicorette® Gum 4 mg
Hide Arm/Group Description:
Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
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; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
12 doses of NICORETTE® gum 4 mg over 11 hours
Overall Number of Participants Analyzed 39 35 32 35 32
Geometric Mean (Standard Deviation)
Unit of Measure: (ng/ml)
13.33  (5.55) 14.04  (4.50) 27.50  (9.18) 23.70  (9.86) 22.15  (7.49)
3.Secondary Outcome
Title Time of Maximum Concentration
Hide Description The time at which maximum concentration is reached (Tmax)
Time Frame During the last dosing interval (hour 11-12 post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Oral Nicotine 24-SA Oral Nicotine 24 Oral Nicotine 48 NiQuitin™ Lozenge 4 mg Nicorette® Gum 4 mg
Hide Arm/Group Description:
Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
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; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
12 doses of NICORETTE® gum 4 mg over 11 hours
Overall Number of Participants Analyzed 39 35 32 35 32
Median (Full Range)
Unit of Measure: (minutes)
15.0
(5.0 to 42.0)
10.0
(5.0 to 45.0)
10.0
(5.0 to 23.0)
25.0
(13.0 to 55.0)
30.0
(10.0 to 50.0)
4.Secondary Outcome
Title Minimum Plasma Concentration
Hide Description The minimum nicotine plasma concentration during the last dosing interval (Cmin)
Time Frame During the last dosing interval (hour 11-12 post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Oral Nicotine 24-SA Oral Nicotine 24 Oral Nicotine 48 NiQuitin™ Lozenge 4 mg Nicorette® Gum 4 mg
Hide Arm/Group Description:
Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
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; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
12 doses of NICORETTE® gum 4 mg over 11 hours
Overall Number of Participants Analyzed 39 35 32 35 32
Mean (Standard Deviation)
Unit of Measure: (ng/ml)
11.54  (4.71) 11.67  (4.04) 25.32  (8.41) 22.14  (9.71) 19.00  (7.00)
5.Secondary Outcome
Title Peak-Trough Fluctuation
Hide Description Percent of peak-trough fluctuation over one dosing interval at steady state (PTF)
Time Frame During the last dosing interval (hour 11-12 post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Oral Nicotine 24-SA Oral Nicotine 24 Oral Nicotine 48 NiQuitin™ Lozenge 4 mg Nicorette® Gum 4 mg
Hide Arm/Group Description:
Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
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; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
12 doses of NICORETTE® gum 4 mg over 11 hours
Overall Number of Participants Analyzed 39 35 32 35 32
Mean (Standard Deviation)
Unit of Measure: Percent Fluctuation
35.6  (14.2) 38.4  (14.9) 21.7  (8.7) 29.1  (10.7) 36.3  (12.8)
6.Secondary Outcome
Title Nicotine Plasma Concentration
Hide Description The nicotine concentration in plasma (area under the nicotine plasma concentration curve) 1 hour after start of treatment
Time Frame One hour after start of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Oral Nicotine 24-SA Oral Nicotine 24
Hide Arm/Group Description:
Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
Overall Number of Participants Analyzed 36 34
Geometric Mean (Standard Deviation)
Unit of Measure: (ng/ml)
4.49  (1.60) 4.76  (1.45)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oral Nicotine 24-SA Oral Nicotine 24 Oral Nicotine 48 NiQuitin™ Lozenge 4 mg Nicorette® Gum 4 mg
Hide Arm/Group Description Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours 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; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours 12 doses of NICORETTE® gum 4 mg over 11 hours
All-Cause Mortality
Oral Nicotine 24-SA Oral Nicotine 24 Oral Nicotine 48 NiQuitin™ Lozenge 4 mg Nicorette® Gum 4 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Oral Nicotine 24-SA Oral Nicotine 24 Oral Nicotine 48 NiQuitin™ Lozenge 4 mg Nicorette® Gum 4 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/37 (0.00%)   0/36 (0.00%)   0/35 (0.00%)   0/35 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oral Nicotine 24-SA Oral Nicotine 24 Oral Nicotine 48 NiQuitin™ Lozenge 4 mg Nicorette® Gum 4 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   29/40 (72.50%)   22/37 (59.46%)   27/36 (75.00%)   24/35 (68.57%)   18/35 (51.43%) 
Gastrointestinal disorders           
Abdominal distension  1 [1]  0/40 (0.00%)  1/37 (2.70%)  7/36 (19.44%)  0/35 (0.00%)  5/35 (14.29%) 
Abdominal pain upper  1 [1]  3/40 (7.50%)  1/37 (2.70%)  4/36 (11.11%)  7/35 (20.00%)  6/35 (17.14%) 
Dyspepsia  1 [1]  2/40 (5.00%)  2/37 (5.41%)  1/36 (2.78%)  2/35 (5.71%)  3/35 (8.57%) 
Eructation  1 [1]  2/40 (5.00%)  2/37 (5.41%)  1/36 (2.78%)  1/35 (2.86%)  6/35 (17.14%) 
Nausea  1 [1]  5/40 (12.50%)  3/37 (8.11%)  4/36 (11.11%)  4/35 (11.43%)  4/35 (11.43%) 
Salivary hypersecretion  1 [1]  7/40 (17.50%)  0/37 (0.00%)  1/36 (2.78%)  0/35 (0.00%)  3/35 (8.57%) 
Lacrimation Increase  1  0/40 (0.00%)  2/37 (5.41%)  1/36 (2.78%)  0/35 (0.00%)  0/35 (0.00%) 
Diarrheoa  1  1/40 (2.50%)  1/37 (2.70%)  1/36 (2.78%)  1/35 (2.86%)  2/35 (5.71%) 
Flatulence  1  0/40 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  2/35 (5.71%)  1/35 (2.86%) 
Glossodynia  1  2/40 (5.00%)  2/37 (5.41%)  1/36 (2.78%)  0/35 (0.00%)  0/35 (0.00%) 
Oropharyngial Pain  1  0/40 (0.00%)  0/37 (0.00%)  0/36 (0.00%)  2/35 (5.71%)  0/35 (0.00%) 
Infections and infestations           
Nasopharyngitis  1 [1]  2/40 (5.00%)  2/37 (5.41%)  3/36 (8.33%)  3/35 (8.57%)  0/35 (0.00%) 
Nervous system disorders           
Headache  1 [1]  10/40 (25.00%)  6/37 (16.22%)  10/36 (27.78%)  7/35 (20.00%)  7/35 (20.00%) 
Dizziness  1  2/40 (5.00%)  0/37 (0.00%)  1/36 (2.78%)  2/35 (5.71%)  0/35 (0.00%) 
Reproductive system and breast disorders           
Dysmenorrhoea  1  0/40 (0.00%)  0/37 (0.00%)  2/36 (5.56%)  0/35 (0.00%)  0/35 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Hiccups  1 [1]  18/40 (45.00%)  18/37 (48.65%)  18/36 (50.00%)  9/35 (25.71%)  6/35 (17.14%) 
Throat irritation  1 [1]  0/40 (0.00%)  0/37 (0.00%)  1/36 (2.78%)  2/35 (5.71%)  3/35 (8.57%) 
Throat tightness  1  3/40 (7.50%)  0/37 (0.00%)  0/36 (0.00%)  0/35 (0.00%)  3/35 (8.57%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
[1]
Total number of subjects affected in the safety analysis set in arms where the data lies above the 5% threshold
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Joyce Hauze, Sr. Specialist, Clinical Research Operations
Organization: J&J Consumer and Personal Products Worldwide
Phone: 928-277-0715
Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier: NCT01084707     History of Changes
Other Study ID Numbers: NICTDP1066-A6431117
2008-006279-65 ( EudraCT Number )
First Submitted: March 9, 2010
First Posted: March 10, 2010
Results First Submitted: April 16, 2010
Results First Posted: October 19, 2010
Last Update Posted: July 13, 2012