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Post Marketing Surveillance Study of Champix in Smoking Cessation for Filipino Patients

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00794365
First received: November 19, 2008
Last updated: November 19, 2010
Last verified: November 2010
History of Changes
Results First Received: November 19, 2010  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Smoking Cessation
Intervention: Drug: Varenicline

  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
Varenicline Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).

Participant Flow:   Overall Study
    Varenicline  
STARTED     330  
COMPLETED     251  
NOT COMPLETED     79  
Lost to Follow-up                 38  
Unspecified                 17  
Poor Compliance                 11  
Adverse Event                 10  
Lack of Efficacy                 3  



  Baseline Characteristics
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Reporting Groups
  Description
Varenicline Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).

Baseline Measures
    Varenicline  
Number of Participants  
[units: participants]
 		  330  
Age, Customized [1]
[units: participants]
 		 
Less than 18 years     2  
18 to 44 years     137  
45 to 64 years     137  
65 years and older     22  
Unspecified     32  
Gender  
[units: participants]
 		 
Female     55  
Male     275  
Total score on the Fagerstrom Test for Nicotine Dependence [2]
[units: scores on a scale]
Mean ± Standard Deviation 		  4.2  ± 2.4  
Fagerstrom Test for Nicotine Dependence (FTND): Time to first cigarette after waking [3]
[units: percentage of participants]
 		 
Within 5 minutes after waking     21.2  
6 to 30 minutes after waking     35.2  
31 to 60 minutes after waking     18.2  
More than 60 minutes after waking     25.5  
Fagerstrom Test for Nicotine Dependence: Ability to refrain from smoking where it is forbidden [4]
[units: percentage of participants]
 		 
Yes     49.1  
No     50.9  
Fagerstrom Test for Nicotine Dependence: Most difficult cigarette to give up [5]
[units: percentage of participants]
 		 
The first cigarette in the morning     38.2  
Any other cigarette     58.8  
No information     3.0  
Fagerstrom Test for Nicotine Dependence: Cigarettes a day [6]
[units: percentage of participants]
 		 
10 cigarettes or less     21.2  
11 to 20 cigarettes     49.4  
21 to 30 cigarettes     20.3  
31 or more cigarettes     7.9  
No information     1.2  
Fagerstrom Test for Nicotine Dependence: Frequency of smoking during first hours after waking [7]
[units: percentage of participants]
 		 
Yes     47.3  
No     52.1  
No information     0.6  
Fagerstrom Test for Nicotine Dependence: Smoking when ill [8]
[units: percentage of participants]
 		 
Yes     26.4  
No     72.7  
No information     0.9  
[1] This study intended to enroll adult smokers aged ≥18 years; however, 2 participants enrolled were younger than 18 years (17 years).
[2] The self-administered Fagerstrom Test for Nicotine Dependence questionnaire assesses level of nicotine dependence. Total score: 0 to 2=very low dependence; 3 to 4=low dependence; 5=medium dependence; 6 to 7=high dependence; 8 to 10=very high dependence.
[3] FTND: responses to "How soon after waking up, did the subject smoke his first cigarette?" Response categories = within 5 minutes after waking, 6 to 30 minutes after waking, 31 to 60 minutes after waking, and after 60 minutes of awakening. Percentage of participants in each category.
[4] FTND: responses to "Did the subject find it difficult to refrain from smoking in places where it is forbidden eg, in church, at the library, in cinema, etc?" Yes = found it difficult to refrain; No = did not find it difficult to refrain. Percentage of participants in each category.
[5] FTND: responses to "Which cigarette would the subject hate the most to give up?" Response categories = First cigarette in the morning, Any other cigarette, and No information (no response given). Percentage of participants in each category.
[6] FTND: responses to "How many cigarettes/day did the subject smoke?" Response categories for number of cigarettes smoked a day = 10 or less, 11 to 20, 21 to 30, 31 or more, and No information (no response given). Percentage of participants in each category.
[7] FTND: responses to "Did the subject smoke more frequently during first hours after waking than during the rest of the day?" Yes = smoked more frequently during first hours after waking; No = did not smoke more frequently during first hours after waking; No information = no response given. Percentage of participants in each category.
[8] FTND: responses to "Did the subject smoke if he is so ill that he is almost in bed most of the day?" Yes = smoked when so ill participant was almost in bed most of the day; No = did not smoke when so ill participant was almost in bed most of the day; No information = no response given. Percentage of participants in each category.



  Outcome Measures
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1.  Primary:   Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 4   [ Time Frame: Week 4 ]
  Show Outcome Measure 1

2.  Primary:   Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 8   [ Time Frame: Week 8 ]
  Show Outcome Measure 2

3.  Primary:   Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 3


  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
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Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00794365     History of Changes
Other Study ID Numbers: A3051079
Study First Received: November 19, 2008
Results First Received: November 19, 2010
Last Updated: November 19, 2010
Health Authority: Philippines: Bureau of Food and Drugs