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The primary objective of this Post-Marketing Study is to monitor the safety of a novel smoking cessation drug Varenicline (Champixâ„¢) 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 (Champixâ„¢) as an aid in smoking cessation based on the 7-day point prevalence of smoking cessation
The study will enroll smoking patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline | Drug | There are two packs available for Varenicline (Champixâ„¢). 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 (Champixâ„¢) 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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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 (Champixâ„¢) by physicians.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21838412 | Derived | Park PW, Casiano EM, Escoto L, Claveria AM. Observational study of safety and efficacy of varenicline for smoking cessation among Filipino smokers. Curr Med Res Opin. 2011 Oct;27(10):1869-75. doi: 10.1185/03007995.2011.607436. Epub 2011 Aug 12. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | This study intended to enroll adult smokers aged ≥18 years; however, 2 participants enrolled were younger than 18 years (17 years). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
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| Adverse Event |
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| Lack of Efficacy |
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| Number |
| participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Total score on the Fagerstrom Test for Nicotine Dependence | 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. | Mean | Standard Deviation | scores on a scale |
|
| Fagerstrom Test for Nicotine Dependence (FTND): Time to first cigarette after waking | 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. | Number | percentage of participants |
|
| Fagerstrom Test for Nicotine Dependence: Ability to refrain from smoking where it is forbidden | 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. | Number | percentage of participants |
|
| Fagerstrom Test for Nicotine Dependence: Most difficult cigarette to give up | 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. | Number | percentage of participants |
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| Fagerstrom Test for Nicotine Dependence: Cigarettes a day | 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. | Number | percentage of participants |
|
| Fagerstrom Test for Nicotine Dependence: Frequency of smoking during first hours after waking | 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. | Number | percentage of participants |
|
| Fagerstrom Test for Nicotine Dependence: Smoking when ill | 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. | Number | percentage of participants |
|
|
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| Primary | 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. | Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 8 |
|
|
|
| Primary | 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. | Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 |
|
|
|
| 0 |
| 330 |
| 44 |
| 330 |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
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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.
| D011810 | Quinoxalines |