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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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  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 ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
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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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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: Joyce Hauze, Sr Specialist, Clinical Research Operations
Organization: J&J Consumer and Personal Products Worldwide
phone: 928-277-0715
e-mail: jhauze@its.jnj.com


No publications provided


Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier: NCT00749463     History of Changes
Other Study ID Numbers: NICTDP4009
Study First Received: September 8, 2008
Results First Received: April 23, 2010
Last Updated: July 6, 2012
Health Authority: China: Ethics Committee