An observational study in Smoking Cessation, sponsored by Pfizer. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-12-20.
Sponsored by Pfizer · Observational
The primary objective of this Post-Marketing Study is to monitor the safety of a novel smoking cessation drug Varenicline (Champix™) 0.5 mg and 1 mg tablets as used in clinical practice for 12 weeks among Filipino smokers.
The secondary objective is to further evaluate the effectiveness of Varenicline (Champix™) as an aid in smoking cessation based on the 7-day point prevalence of smoking cessation
The study will enroll smoking patients.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
This post-marketing surveillance study will be conducted nationwide and will enroll approximately 3,000 study patients. Subject enrollment of less than 3,000 will be acceptable in case of less than expected use of Varenicline (Champix™) by physicians.
Exclusion Criteria:
Drug: Varenicline
There are two packs available for Varenicline (Champix™). The titration pack is prescribed initially to subjects with the recommended 1-week titration phase schedule as follows: Days 1-3 0.5 mg once daily Days 4-7 0.5 mg twice daily Day 8 - End of treatment 1 mg twice daily Following the titration period, Varenicline (Champix™) dosing is increased to 1mg twice daily for the remainder of the treatment period. Patient should set the target quit date to coincide with the start of 1 mg twice daily dosing. It should be taken after eating and with a full glass of water.
Also known as: Chantix, Champix
Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 4
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
Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 8
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
Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 12
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
| Milestone | Varenicline |
|---|---|
| Started | 330 |
| Completed | 251 |
| Not completed | 79 |
| Withdrew: Lost to follow-up | 38 |
| Withdrew: Other | 17 |
| Withdrew: Poor compliance | 11 |
| Withdrew: Adverse event | 10 |
| Withdrew: Lack of efficacy | 3 |
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.
| percentage of participants | Varenicline |
|---|---|
| Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 4 | 58.79 (53.27 to 64.15) |
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.
| percentage of participants | Varenicline |
|---|---|
| Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 8 | 61.52 (56.03 to 66.79) |
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.
| percentage of participants | Varenicline |
|---|---|
| Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 12 | 57.58 (52.04 to 62.97) |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Varenicline | — | 0/330 (0%) | 44/330 (13.3%) |
| Event | Varenicline |
|---|---|
| HeadacheNervous system disorders | 17/330 |
| DizzinessNervous system disorders | 13/330 |
| NauseaGastrointestinal disorders | 12/330 |
| Weight increasedInvestigations | 6/330 |
| Abdominal pain upperGastrointestinal disorders | 5/330 |
| InsomniaPsychiatric disorders | 5/330 |
| Age, Customized(participants) | Varenicline |
|---|---|
| Less than 18 years | 2 |
| 18 to 44 years | 137 |
| 45 to 64 years | 137 |
| 65 years and older | 22 |
| Unspecified | 32 |
| Sex: Female, Male(Participants) | Varenicline |
|---|---|
| Female | 55 |
| Male | 275 |
| Total score on the Fagerstrom Test for Nicotine Dependence(scores on a scale) | Varenicline |
|---|---|
| Mean | 4.2 ± 2.4 |
| Fagerstrom Test for Nicotine Dependence (FTND): Time to first cigarette after waking(percentage of participants) | Varenicline |
|---|---|
| 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(percentage of participants) | Varenicline |
|---|---|
| Yes | 49.1 |
| No | 50.9 |
| Fagerstrom Test for Nicotine Dependence: Most difficult cigarette to give up(percentage of participants) | Varenicline |
|---|---|
| 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(percentage of participants) | Varenicline |
|---|---|
| 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(percentage of participants) | Varenicline |
|---|---|
| Yes | 47.3 |
| No | 52.1 |
| No information | 0.6 |
1 further baseline measures are reported on the registry.
No study locations are listed for this record.
This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.
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