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Evaluation of the Safety Profile, Quit and Reduction Rate After Nicorette® Gum and Patch Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:
NCT00749463
First received: September 8, 2008
Last updated: July 6, 2012
Last verified: July 2012
History of Changes
Results First Received: April 23, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Tobacco Dependence
Interventions: Drug: Nicotine Gum
Drug: Nicotine Patch

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Nicotine Gum 2 Dosage: 2 mg, Dosage Form: Gum
Nicotine Gum 4 Dosage: 4 mg, Dosage Form: Gum
Nicotine Patch Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch

Participant Flow:   Overall Study
    Nicotine Gum 2     Nicotine Gum 4     Nicotine Patch  
STARTED     86     64     150  
COMPLETED     85     60     149  
NOT COMPLETED     1     4     1  
Adverse Event                 0                 4                 1  
Withdrawal by Subject                 1                 0                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Nicotine Gum 2 Dosage: 2 mg, Dosage Form: Gum
Nicotine Gum 4 Dosage: 4 mg, Dosage Form: Gum
Nicotine Patch Dosage: Step-down treatment 15 mg,10 mg, then 5 mg/16 hours Dosage Form: Patch
Total Total of all reporting groups

Baseline Measures
    Nicotine Gum 2     Nicotine Gum 4     Nicotine Patch     Total  
Number of Participants  
[units: participants]
 		  86     64     150     300  
Age  
[units: years]
Mean ± Standard Deviation 		  40.6  ± 10.2     40.3  ± 10.0     41.7  ± 11.6     41.1  ± 10.9  
Gender  
[units: participants]
 		       
Female     0     2     1     3  
Male     86     62     149     297  
Region of Enrollment  
[units: participants]
 		       
China     86     64     150     300  



  Outcome Measures
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1.  Primary:   Treatment-Related Adverse Events   [ Time Frame: 24 Weeks ]
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2.  Primary:   Self-Reported Smoking Reduction   [ Time Frame: 24 Weeks ]
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3.  Primary:   Smoking Abstinence   [ Time Frame: 24 Weeks ]
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4.  Secondary:   Carbon Monoxide (CO)-Verified Smoking Reduction   [ Time Frame: Baseline to Week 24 ]
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5.  Secondary:   Smoking Consumption Per Day   [ Time Frame: 24 Weeks from last visit: ]
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6.  Secondary:   Smoking Consumption Per Week   [ Time Frame: 24 Weeks from last visit: ]
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7.  Secondary:   Point Prevalence Smoking Abstinence (PPSA)   [ Time Frame: 24 Weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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