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

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ClinicalTrials.gov Identifier: NCT00794365
Recruitment Status : Completed
First Posted : November 20, 2008
Results First Posted : December 20, 2010
Last Update Posted : December 20, 2010
Sponsor:
Information provided by:
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Smoking Cessation
Intervention Drug: Varenicline
Enrollment 330
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Varenicline
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 330
Completed 251
Not Completed 79
Reason Not Completed
Lost to Follow-up             38
Other             17
Poor Compliance             11
Adverse Event             10
Lack of Efficacy             3
Arm/Group Title Varenicline
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 330
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 330 participants
Less than 18 years 2
18 to 44 years 137
45 to 64 years 137
65 years and older 22
Unspecified 32
[1]
Measure Description: This study intended to enroll adult smokers aged ≥18 years; however, 2 participants enrolled were younger than 18 years (17 years).
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 330 participants
Female
55
  16.7%
Male
275
  83.3%
Total score on the Fagerstrom Test for Nicotine Dependence   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 330 participants
4.2  (2.4)
[1]
Measure Description: 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.
Fagerstrom Test for Nicotine Dependence (FTND): Time to first cigarette after waking   [1] 
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 330 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
[1]
Measure Description: 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.
Fagerstrom Test for Nicotine Dependence: Ability to refrain from smoking where it is forbidden   [1] 
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 330 participants
Yes 49.1
No 50.9
[1]
Measure Description: 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.
Fagerstrom Test for Nicotine Dependence: Most difficult cigarette to give up   [1] 
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 330 participants
The first cigarette in the morning 38.2
Any other cigarette 58.8
No information 3.0
[1]
Measure Description: 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.
Fagerstrom Test for Nicotine Dependence: Cigarettes a day   [1] 
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 330 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
[1]
Measure Description: 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.
Fagerstrom Test for Nicotine Dependence: Frequency of smoking during first hours after waking   [1] 
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 330 participants
Yes 47.3
No 52.1
No information 0.6
[1]
Measure Description: 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.
Fagerstrom Test for Nicotine Dependence: Smoking when ill   [1] 
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 330 participants
Yes 26.4
No 72.7
No information 0.9
[1]
Measure Description: 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.
1.Primary Outcome
Title Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 4
Hide Description Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: “In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?”. Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 330
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
58.79
(53.27 to 64.15)
2.Primary Outcome
Title Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 8
Hide Description Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: “In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?”. Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 330
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
61.52
(56.03 to 66.79)
3.Primary Outcome
Title Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 12
Hide Description Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: “In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?”. Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets.
Arm/Group Title Varenicline
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 330
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
57.58
(52.04 to 62.97)
Time Frame [Not Specified]
Adverse Event Reporting Description Safety population: all subjects who received at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
 
Arm/Group Title Varenicline
Hide Arm/Group Description 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).
All-Cause Mortality
Varenicline
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline
Affected / at Risk (%)
Total   0/330 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Varenicline
Affected / at Risk (%)
Total   44/330 (13.33%) 
Gastrointestinal disorders   
Abdominal pain upper  1  5/330 (1.52%) 
Nausea  1  12/330 (3.64%) 
Investigations   
Weight increased  1  6/330 (1.82%) 
Nervous system disorders   
Dizziness  1  13/330 (3.94%) 
Headache  1  17/330 (5.15%) 
Psychiatric disorders   
Insomnia  1  5/330 (1.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00794365     History of Changes
Other Study ID Numbers: A3051079
First Submitted: November 19, 2008
First Posted: November 20, 2008
Results First Submitted: November 19, 2010
Results First Posted: December 20, 2010
Last Update Posted: December 20, 2010