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Study to Determine if a New Nicotine Replacement Therapy Can Safely Help Smokers to Quit Smoking

This study has been terminated.
(Study terminated due to a technical issue (randomization error).)
Sponsor:
Collaborators:
McNeil AB
GlaxoSmithKline
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. )
ClinicalTrials.gov Identifier:
NCT01296698
First received: February 14, 2011
Last updated: March 29, 2012
Last verified: March 2012
History of Changes
Results First Received: March 29, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Tobacco Dependence
Interventions: Drug: Placebo
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
No text entered.

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
Placebo 0 mg Oral NRT, up to 4 times per hour for 12 weeks
Nicotine 1 mg Oral NRT, up to 4 times per hour for 12 weeks

Participant Flow:   Overall Study
    Placebo     Nicotine  
STARTED     244     13  
COMPLETED     0     0  
NOT COMPLETED     244     13  
Adverse Event                 1                 0  
Death                 1                 0  
Lost to Follow-up                 19                 1  
Withdrawal by Subject                 12                 0  
Difficulty Contacting Subject                 2                 0  
Study Terminated by Sponsor                 209                 12  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo 0 mg Oral NRT, up to 4 times per hour for 12 weeks
Nicotine 1 mg Oral NRT, up to 4 times per hour for 12 weeks
Total Total of all reporting groups

Baseline Measures
    Placebo     Nicotine     Total  
Number of Participants  
[units: participants]
 		  244     13     257  
Age  
[units: years]
Mean ± Standard Deviation 		  47.1  ± 14.0     49.9  ± 11.4     47.2  ± 13.9  
Gender  
[units: participants]
 		     
Female     131     8     139  
Male     113     5     118  
Region of Enrollment  
[units: participants]
 		     
United States     244     13     257  



  Outcome Measures
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1.  Primary:   Number of Participants With Continuous Smoking Abstinence   [ Time Frame: through Week 6 ]
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2.  Secondary:   Number of Participants With Continuous Smoking Abstinence   [ Time Frame: through Week 26 ]
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3.  Secondary:   Number of Participants With 7-day Point Prevalence Abstinence   [ Time Frame: through Week 26 ]
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4.  Secondary:   Mean Number of Daily Doses   [ Time Frame: Week 1 ]
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5.  Secondary:   Mean Number of Daily Doses   [ Time Frame: Week 2 ]
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6.  Secondary:   Mean Number of Daily Doses   [ Time Frame: Week 3 ]
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7.  Secondary:   Mean Number of Daily Doses   [ Time Frame: Week 4 ]
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8.  Secondary:   Mean Number of Daily Doses   [ Time Frame: Week 5 ]
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9.  Secondary:   Mean Number of Daily Doses   [ Time Frame: Week 6 ]
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10.  Secondary:   Percentage of Participants With High Dosage   [ Time Frame: within 12 Weeks ]
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11.  Secondary:   Percentage of Participants With High Usage   [ Time Frame: within 12 Weeks ]
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12.  Secondary:   Highest Rating of Desire/Urge to Smoke on a Categorical Scale   [ Time Frame: within 12 Weeks ]
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13.  Secondary:   Highest Rating of Irritability/Frustration/Anger on a Categorical Scale   [ Time Frame: within 12 Weeks ]
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14.  Secondary:   Highest Rating of Restlessness on a Categorical Scale   [ Time Frame: within 12 Weeks ]
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15.  Secondary:   Highest Rating of Difficulty Concentrating on a Categorical Scale   [ Time Frame: within 12 Weeks ]
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16.  Secondary:   Highest Rating of Anxiety on a Categorical Scale   [ Time Frame: within 12 Weeks ]
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17.  Secondary:   Highest Rating of Dysphoric or Depressed Mood on a Categorical Scale   [ Time Frame: within 12 Weeks ]
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18.  Secondary:   Highest Rating of Insomnia on a Categorical Scale   [ Time Frame: within 12 Weeks ]
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19.  Secondary:   Highest Rating of Increased Appetite on a Categorical Scale   [ Time Frame: within 12 Weeks ]
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20.  Secondary:   Participant Score for General Perception of the Product   [ Time Frame: through Week 12 ]
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21.  Secondary:   Participant Score for Product Effectiveness in Dealing With Cravings   [ Time Frame: through 12 Weeks ]
  Hide Outcome Measure 21

Measure Type Secondary
Measure Title Participant Score for Product Effectiveness in Dealing With Cravings
Measure Description Participants are asked to rate the product in its effectiveness for dealing with cravings, on a scale of 1-5, where 1=not at all effective, and 5=extremely effective.
Time Frame through 12 Weeks  
Safety Issue No  

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.
The study was terminated prematurely due to a technical issue (randomization error) and no data are available.

Reporting Groups
  Description
Placebo 0 mg Oral NRT, up to 4 times per hour for 12 weeks
Nicotine 1 mg Oral NRT, up to 4 times per hour for 12 weeks

Measured Values
    Placebo     Nicotine  
Number of Participants Analyzed  
[units: participants]
 		  0     0  
Participant Score for Product Effectiveness in Dealing With Cravings  
[units: Units on a scale]
Mean ± Standard Deviation 		       

No statistical analysis provided for Participant Score for Product Effectiveness in Dealing With Cravings



22.  Secondary:   Participant Score for Speed of Action   [ Time Frame: through 12 Weeks ]
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23.  Secondary:   Participant Score for Change in Perception   [ Time Frame: through 12 Weeks ]
  Show Outcome Measure 23

24.  Secondary:   Participant Score for Product Convenience   [ Time Frame: through 12 Weeks ]
  Show Outcome Measure 24


  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 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
Summary tabulations are not available for the primary and some secondary outcome measures because the study was terminated early due to a technical issue (randomization error).  


Results Point of Contact:  
Name/Title: Joyce Hauze, RPS Sr. Specialist, Clinical Research Operations
Organization: Johnson & Johnson 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 Consumer Healthcare Division of McNEIL-PPC, Inc. )
ClinicalTrials.gov Identifier: NCT01296698     History of Changes
Other Study ID Numbers: A6431112
Study First Received: February 14, 2011
Results First Received: March 29, 2012
Last Updated: March 29, 2012
Health Authority: United States: Food and Drug Administration