Smoking Cessation
Conditions
Keywords
Smoking, smoking cessation, Japanese, varenicline, retreatment, Regulatory Post Marketing Commitment Plan
Brief summary
The purpose of this study is to collect the efficacy and safety information in subjects who have been retreated with varenicline (Champix®) within 52 weeks of initial treatment for their appropriate use in daily practice and are participants for varenicline Drug Use Investigation protocol A3051109 ((NCT# NCT00772941).
Detailed description
The subjects have been retreated with varenicline within 52 weeks, and subjects have been enrolled to varenicline Drug Use Investigation protocol A3051109.
Interventions
DRUGvarenicline
Dosage form: tablet 0.5mg, tablet 1mg. The usual adult dosage for oral use is 0.5 mg once daily after eating on Days 1 to 3; 0.5 mg twice daily after eating in the morning and evening on Days 4 to 7, and 1 mg twice daily after eating in the morning and evening on Day 8 and thereafter. The drug should be administered to subjects for 12 weeks.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Male or Female subjects intend to quit tobacco use who are prescribed varenicline (Champix®) by their Physicians * Subjects who are prescribed varenicline (Champix®) for the second time within 52 weeks of initial treatment.
Exclusion criteria
Non-participants of varenicline (Champix®) Drug use Investigation protocol A3051109.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events (AEs) | 24 weeks | An AE was any untoward medical occurrence attributed to veranicline in a participant who received veranicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline. |
| Number of Responders to Varenicline Treatment | 24 weeks | Number of participants who succeeded in smoking cessation from 12 weeks through 24 weeks of the observation period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment-Related Adverse Events (AEs) Unlisted in Japanese Package Insert | 24 weeks | An AE was any untoward medical occurrence attributed to varenicline in a participant who received varenicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline. |
| Number of Participants With Risk Factors Likely to Affect the Frequency of Treatment-Related Adverse Events (AEs) | 24 weeks | — |
| Number of Participants With Risk Factors Likely to Affect the Proportion of Responders | 24 weeks | — |
Participant flow
Pre-assignment details
This survey enrolled those who participated in preceding varenicline Drug Use Investigation protocol A3051109 (NCT00772941) and retreated with varenicline within 52 weeks of initial treatment.
Participants by arm
| Arm | Count |
|---|---|
| Varenicline (Champix®) The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment. | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 14 |
Baseline characteristics
| Characteristic | Varenicline (Champix®) |
|---|---|
| Age, Customized <65 years | 3 participants |
| Age, Customized >=65 years | 3 participants |
| Sex/Gender, Customized Female | 0 participants |
| Sex/Gender, Customized Male | 6 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Number of Participants With Treatment-Related Adverse Events (AEs)
An AE was any untoward medical occurrence attributed to veranicline in a participant who received veranicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline.
Time frame: 24 weeks
Population: The safety analysis population comprised participants who had been enrolled in varenicline protocol A3051109 and retreated with varenicline within 52 weeks of initial treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline (Champix®) | Number of Participants With Treatment-Related Adverse Events (AEs) | 0 Participants |
Primary
Number of Responders to Varenicline Treatment
Number of participants who succeeded in smoking cessation from 12 weeks through 24 weeks of the observation period.
Time frame: 24 weeks
Population: The efficacy analysis population comprised the participants who had at least one post-baseline efficacy measurement among the safety analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline (Champix®) | Number of Responders to Varenicline Treatment | 2 Participants |
Secondary
Number of Participants With Risk Factors Likely to Affect the Frequency of Treatment-Related Adverse Events (AEs)
Time frame: 24 weeks
Population: The safety analysis population comprised participants who had been enrolled in varenicline protocol A3051109 and retreated with varenicline within 52 weeks of initial treatment. Because of the small population size, no risk analyses were performed.
Secondary
Number of Participants With Risk Factors Likely to Affect the Proportion of Responders
Time frame: 24 weeks
Population: The efficacy analysis population comprised the participants who had at least one post-baseline efficacy measurement among the safety analysis population. Because of the small population size, no risk analyses were performed.
Secondary
Number of Treatment-Related Adverse Events (AEs) Unlisted in Japanese Package Insert
An AE was any untoward medical occurrence attributed to varenicline in a participant who received varenicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline.
Time frame: 24 weeks
Population: The safety analysis population comprised participants who had been enrolled in varenicline protocol A3051109 and retreated with varenicline within 52 weeks of initial treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline (Champix®) | Number of Treatment-Related Adverse Events (AEs) Unlisted in Japanese Package Insert | 0 Participants |