Oral Tolerability Of Two Nicotine Dosage Forms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00682461
First received: May 20, 2008
Last updated: January 24, 2013
Last verified: January 2013
Results First Received: January 24, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Healthy Volunteer Smokers
Intervention: Drug: Nicotine

  Participant Flow
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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 one clinical site in the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Nicotine Mouth Strip (2.5 mg) Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
Nicotine Lozenge (2.0 mg) Prticipants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day

Participant Flow:   Overall Study
    Nicotine Mouth Strip (2.5 mg)     Nicotine Lozenge (2.0 mg)  
STARTED     100     100  
COMPLETED     75     69  
NOT COMPLETED     25     31  
Adverse Event                 5                 7  
Lost to Follow-up                 8                 5  
Withdrawal by Subject                 12                 19  



  Baseline Characteristics
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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
Nicotine Mouth Strip (2.5 mg) Participants were instructed to take 2.5 mg Nicotine Mouth Strip, not exceeding a maximum limit of 15 per day
Nicotine Lozenge (2.0 mg) Participants were instructed to take 2.0 mg Nicotine Lozenge, not exceeding a maximum limit of 15 per day
Total Total of all reporting groups

Baseline Measures
    Nicotine Mouth Strip (2.5 mg)     Nicotine Lozenge (2.0 mg)     Total  
Number of Participants  
[units: participants]
  100     100     200  
Age  
[units: Years]
Mean ± Standard Deviation
  42.32  ± 11.79     42.84  ± 12.34     42.58  ± 12.042  
Gender  
[units: Participants]
     
Female     62     63     125  
Male     38     37     75  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 1   [ Time Frame: From baseline to Week 1 ]

2.  Primary:   Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 6   [ Time Frame: From baseline to Week 6 ]

3.  Primary:   Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 12   [ Time Frame: From baseline to Week 12 ]

4.  Primary:   Percentage of Participants With Oral Soft Tissue Related Adverse Events at Week 14   [ Time Frame: From baseline to Week 14 ]

5.  Secondary:   Percentage of Participants With Adverse Events   [ Time Frame: From baseline to Week 14 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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.


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


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00682461     History of Changes
Other Study ID Numbers: S2110367
Study First Received: May 20, 2008
Results First Received: January 24, 2013
Last Updated: January 24, 2013
Health Authority: United States: Food and Drug Administration