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The aim of this study is to determine the success rates for stopping smoking with varenicline in Germany. The main measure of success will be continuous abstinence from smoking (not a single puff) in the last week of the standard 12 week treatment period. Additional information will be gathered regarding prescribing practices in Germany, smoking history, reasons why smokers quit smoking and re-start smoking, smoking related illnesses and the tolerability of varenicline.
Sampling Method Details: Non-interventional study: subjects to be selected according to the usual clinical practice of their physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single group prospective treatment cohort (varenicline) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline | Drug | varenicline tablets prescribed as per local German SmPC for 12 weeks duration |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Abstained From Smoking at Week 12 | The use of nicotine was recorded using Nicotine Use Inventory (NUI) to determine the participants who abstained from smoking for the previous 7 days. A responder for the 7-day point prevalence was defined as those with 'no' answers to the following two questions: Did the participant smoke any cigarettes (even a puff) in the last 7 days; and did participant use any other tobacco products (example pipe, cigars, snuff, chewing tobacco) in the last 7 days. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Nicotine Dependence Measured by the Fagerstrom Test | Fagerstrom Test for Nicotine Dependence (FTND) was designed to provide measure of nicotine dependence related to cigarette smoking. It contains 4 yes-no and 2 multiple choice questions. Items are scored 0-3 for multiple choice items, items are summed to yield total score of 0-10 (0=minimum to 10=maximum nicotine dependence). | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Adult smokers who are willing and motivated to stop smoking
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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A total of 1391 participants were screened and 1177 participants were assigned to the treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Varenicline | Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Varenicline | Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Demographic data for 4 participants was not available. | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Demographic data for 4 participants was not available. | Number | participants |
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| 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 Who Abstained From Smoking at Week 12 | The use of nicotine was recorded using Nicotine Use Inventory (NUI) to determine the participants who abstained from smoking for the previous 7 days. A responder for the 7-day point prevalence was defined as those with 'no' answers to the following two questions: Did the participant smoke any cigarettes (even a puff) in the last 7 days; and did participant use any other tobacco products (example pipe, cigars, snuff, chewing tobacco) in the last 7 days. | The all participants' population included all enrolled participants who had received at least 1 dose (including partial doses) of study medication. Missing observations were not imputed and hence the participants analyzed are the ones without missing values. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 |
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| Secondary | Level of Nicotine Dependence Measured by the Fagerstrom Test | Fagerstrom Test for Nicotine Dependence (FTND) was designed to provide measure of nicotine dependence related to cigarette smoking. It contains 4 yes-no and 2 multiple choice questions. Items are scored 0-3 for multiple choice items, items are summed to yield total score of 0-10 (0=minimum to 10=maximum nicotine dependence). | The all participants' population included all enrolled participants who had received at least 1 dose (including partial doses) of study medication. Missing observations were not imputed and hence the participants analyzed are the ones without missing values. | Posted | Median | Standard Deviation | Scores on a scale | Baseline |
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity. | 7 | 1,177 | 40 | 1,177 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (v14.0) | Non-systematic Assessment |
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| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA (v14.0) | Non-systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (v14.0) | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (v14.0) | Non-systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA (v14.0) | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (v14.0) | Non-systematic Assessment |
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| Abnormal dreams | Psychiatric disorders | MedDRA (v14.0) | Non-systematic Assessment |
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| Aggression | Psychiatric disorders | MedDRA (v14.0) | Non-systematic Assessment |
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| Apathy | Psychiatric disorders | MedDRA (v14.0) | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (v14.0) | Non-systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA (v14.0) | Non-systematic Assessment |
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| Mood swings | Psychiatric disorders | MedDRA (v14.0) | Non-systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA (v14.0) | Non-systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA (v14.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (v14.0) | Non-systematic Assessment |
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It is highly likely that Adverse Events were under reported for this study as it was a Non Interventional study.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| 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 |
| D011810 | Quinoxalines |
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| Unspecified |
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