Drug Use Investigation Of Varenicline (Regulatory Post Marketing Commitment Plan)

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: Varenicline

• Registration Number: NCT00772941
• Lead Sponsor: Pfizer

Brief Summary

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Detailed Description

All the patients whom an investigator prescribes the first Varenicline(Champix) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Study Timeline

• Study First Submitted: 2008-10-13
• Study First Submitted QC: 2008-10-13
• Study First Posted: 2008-10-15
• Study Start: 2009-02
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2013-12-09
• Results First Submitted QC: 2013-12-09
• Status Verified: 2014-01
• Results First Posted: 2014-01-24
• Last Update Submitted: 2014-01-28
• Last Update Posted: 2014-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3939

Inclusion Criteria

• Patients need to be administered Varenicline(Champix) in order to be enrolled in the surveillance.

Exclusion Criteria

• Patients not administered Varenicline(Champix).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Varenicline	Varenicline	Patients taking Varenicline.

Primary Outcome Measures

Name	Time	Method
Risk Factors for the Frequency of Treatment Related Adverse Events - Gender.	24 weeks	Number of participants with Treatment Related Adverse Events of Varenicline to determine whether gender is a significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events - Age.	24 weeks	Number of participants with Treatment Related Adverse Events of Varenicline to determine whether age is a significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication.	24 weeks	Number of participants with Treatment Related Adverse Events of Varenicline to determine whether Chronic obstructive pulmonary disease as a complication is a significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Drugs.	24 weeks	Number of participants with Treatment Related Adverse Events of Varenicline to determine whether taking concomitant drugs is a significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Therapies.	24 weeks	Number of participants with Treatment Related Adverse Events of Varenicline to determine whether receiving concomitant therapies is a significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline.	24 weeks	Number of participants with Treatment Related Adverse Events to determine whether weight at baseline is a significant risk factor.
Risk Factors for the Proportion of Responders - Tobacco Consumption Per Day.	24 weeks	The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.
Risk Factors for the Proportion of Responders - Prolonged Administration After 12 Weeks.	24 weeks	The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.
Risk Factors for the Proportion of Responders - Antipsychotics as a Concomitant Drug.	24 weeks	The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.
Number of Participants With Treatment Related Adverse Events.	24 weeks	Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Varenicline. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.
Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.	24 weeks	Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Numbers of Treatment Related Adverse Events were evaluated in company with the causal relationship to Varenicline. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Continuous Abstinence Situation by 52 Weeks.	52 weeks	Number of participants with dependence on Varenicline by 52 weeks. Varenicline-dependent Treatment Related Adverse Events are Feeling abnormal, Feeling drunk, Feeling jittery, Disturbance in attention, Dizziness, Memory impairment, Mental impairment, Psychomotor hyperactivity, Sedation, Somnolence, Confusional state, Depersonalisation, Disorientation, Dissociation, Euphoric mood, Mood variable, Mood swings, and Hallucination.