Nicotine Lozenge Bioequivalence Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01536704
First received: December 15, 2011
Last updated: March 14, 2013
Last verified: March 2013
Results First Received: March 14, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Screening
Condition: Smoking Cessation
Interventions: Drug: Nicotine (2 mg)
Drug: Nicotine (4 mg)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited at the clinical site.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 141 participants screened, only 50 were randomized since 91 were screen failures.

Reporting Groups
  Description
2 Milligram (mg) Cherry Lozenge Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
2mg Mint Lozenge Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
4mg Cherry Lozenge Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
4mg Mint Lozenge Participants were instructed to move the 4mg Mint mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.

Participant Flow for 7 periods

Period 1:   Period 1
    2 Milligram (mg) Cherry Lozenge     2mg Mint Lozenge     4mg Cherry Lozenge     4mg Mint Lozenge  
STARTED     12     12     13     13  
COMPLETED     12     12     13     13  
NOT COMPLETED     0     0     0     0  

Period 2:   Washout Period 1
    2 Milligram (mg) Cherry Lozenge     2mg Mint Lozenge     4mg Cherry Lozenge     4mg Mint Lozenge  
STARTED     12     12     13     13  
COMPLETED     11     10     13     13  
NOT COMPLETED     1     2     0     0  
Withdrawal by Subject                 1                 2                 0                 0  

Period 3:   Period 2
    2 Milligram (mg) Cherry Lozenge     2mg Mint Lozenge     4mg Cherry Lozenge     4mg Mint Lozenge  
STARTED     13 [1]   11 [1]   10 [1]   13 [1]
COMPLETED     13     11     10     13  
NOT COMPLETED     0     0     0     0  
[1] Due to crossover design, a different set of subjects received this treatment compared to Period 1

Period 4:   Washout Period 2
    2 Milligram (mg) Cherry Lozenge     2mg Mint Lozenge     4mg Cherry Lozenge     4mg Mint Lozenge  
STARTED     13     11     10     13  
COMPLETED     12     11     10     12  
NOT COMPLETED     1     0     0     1  
Adverse Event                 1                 0                 0                 0  
Withdrawal by Subject                 0                 0                 0                 1  

Period 5:   Period 3
    2 Milligram (mg) Cherry Lozenge     2mg Mint Lozenge     4mg Cherry Lozenge     4mg Mint Lozenge  
STARTED     10 [1]   12 [1]   12 [1]   11 [1]
COMPLETED     10     12     12     10  
NOT COMPLETED     0     0     0     1  
Adverse Event                 0                 0                 0                 1  
[1] Due to crossover design, a different set of subjects received this treatment compared to Period 2

Period 6:   Washout Period 3
    2 Milligram (mg) Cherry Lozenge     2mg Mint Lozenge     4mg Cherry Lozenge     4mg Mint Lozenge  
STARTED     10     12     12     10  
COMPLETED     10     12     11     10  
NOT COMPLETED     0     0     1     0  
Adverse Event                 0                 0                 1                 0  

Period 7:   Period 4
    2 Milligram (mg) Cherry Lozenge     2mg Mint Lozenge     4mg Cherry Lozenge     4mg Mint Lozenge  
STARTED     12 [1]   11 [1]   10 [1]   10 [1]
COMPLETED     12     11     10     10  
NOT COMPLETED     0     0     0     0  
[1] Due to crossover design, a different set of subjects received this treatment compared to Period 3



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Randomized Participants All randomized participants were evaluated for baseline measures

Baseline Measures
    All Randomized Participants  
Number of Participants  
[units: participants]
  50  
Age  
[units: Years]
Mean ± Standard Deviation
  30.3  ± 9.58  
Gender  
[units: Participants]
 
Female     17  
Male     33  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)]   [ Time Frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours ]

2.  Primary:   Maximum Observed Plasma Concentration [Cmaximum (Max)]   [ Time Frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours ]

3.  Secondary:   AUC [0-infinity (Inf)]   [ Time Frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours ]

4.  Secondary:   Time to Reach Maximum Plasma Nicotine Concentration (Tmax)   [ Time Frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours ]

5.  Secondary:   Apparent Elimination Half-life of Nicotine T(1/2)   [ Time Frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours ]

6.  Secondary:   Elimination Rate Constant for Plasma Nicotine: K (el)   [ Time Frame: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01536704     History of Changes
Other Study ID Numbers: S6491365
Study First Received: December 15, 2011
Results First Received: March 14, 2013
Last Updated: March 14, 2013
Health Authority: United States: Food and Drug Administration