Trial Outcomes & Findings for Post Marketing Surveillance Study of Champix in Smoking Cessation for Filipino Patients (NCT NCT00794365)
NCT ID: NCT00794365
Last Updated: 2010-12-20
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
330 participants
Primary outcome timeframe
Week 4
Results posted on
2010-12-20
Participant Flow
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
330
|
|
Overall Study
COMPLETED
|
251
|
|
Overall Study
NOT COMPLETED
|
79
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|
|
Overall Study
Lost to Follow-up
|
38
|
|
Overall Study
Other
|
17
|
|
Overall Study
Poor Compliance
|
11
|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
Lack of Efficacy
|
3
|
Baseline Characteristics
Post Marketing Surveillance Study of Champix in Smoking Cessation for Filipino Patients
Baseline characteristics by cohort
| Measure |
Varenicline
n=330 Participants
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).
|
|---|---|
|
Age, Customized
Less than 18 years
|
2 participants
n=5 Participants
|
|
Age, Customized
18 to 44 years
|
137 participants
n=5 Participants
|
|
Age, Customized
45 to 64 years
|
137 participants
n=5 Participants
|
|
Age, Customized
65 years and older
|
22 participants
n=5 Participants
|
|
Age, Customized
Unspecified
|
32 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
275 Participants
n=5 Participants
|
|
Total score on the Fagerstrom Test for Nicotine Dependence
|
4.2 scores on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence (FTND): Time to first cigarette after waking
Within 5 minutes after waking
|
21.2 percentage of participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence (FTND): Time to first cigarette after waking
6 to 30 minutes after waking
|
35.2 percentage of participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence (FTND): Time to first cigarette after waking
31 to 60 minutes after waking
|
18.2 percentage of participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence (FTND): Time to first cigarette after waking
More than 60 minutes after waking
|
25.5 percentage of participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence: Ability to refrain from smoking where it is forbidden
Yes
|
49.1 percentage of participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence: Ability to refrain from smoking where it is forbidden
No
|
50.9 percentage of participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence: Most difficult cigarette to give up
The first cigarette in the morning
|
38.2 percentage of participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence: Most difficult cigarette to give up
Any other cigarette
|
58.8 percentage of participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence: Most difficult cigarette to give up
No information
|
3.0 percentage of participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence: Cigarettes a day
10 cigarettes or less
|
21.2 percentage of participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence: Cigarettes a day
11 to 20 cigarettes
|
49.4 percentage of participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence: Cigarettes a day
21 to 30 cigarettes
|
20.3 percentage of participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence: Cigarettes a day
31 or more cigarettes
|
7.9 percentage of participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence: Cigarettes a day
No information
|
1.2 percentage of participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence: Frequency of smoking during first hours after waking
Yes
|
47.3 percentage of participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence: Frequency of smoking during first hours after waking
No
|
52.1 percentage of participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence: Frequency of smoking during first hours after waking
No information
|
0.6 percentage of participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence: Smoking when ill
Yes
|
26.4 percentage of participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence: Smoking when ill
No
|
72.7 percentage of participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence: Smoking when ill
No information
|
0.9 percentage of participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets.
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.
Outcome measures
| Measure |
Varenicline
n=330 Participants
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).
|
|---|---|
|
Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 4
|
58.79 percentage of participants
Interval 53.27 to 64.15
|
PRIMARY outcome
Timeframe: Week 8Population: Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets.
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.
Outcome measures
| Measure |
Varenicline
n=330 Participants
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).
|
|---|---|
|
Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 8
|
61.52 percentage of participants
Interval 56.03 to 66.79
|
PRIMARY outcome
Timeframe: Week 12Population: Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets.
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.
Outcome measures
| Measure |
Varenicline
n=330 Participants
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).
|
|---|---|
|
Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 12
|
57.58 percentage of participants
Interval 52.04 to 62.97
|
Adverse Events
Varenicline
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Varenicline
n=330 participants at risk
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).
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.5%
5/330
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.
|
|
Gastrointestinal disorders
Nausea
|
3.6%
12/330
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.
|
|
Investigations
Weight increased
|
1.8%
6/330
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.
|
|
Nervous system disorders
Dizziness
|
3.9%
13/330
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.
|
|
Nervous system disorders
Headache
|
5.2%
17/330
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.
|
|
Psychiatric disorders
Insomnia
|
1.5%
5/330
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER