Post Marketing Surveillance Study of Champix in Smoking Cessation for Filipino Patients

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: Varenicline

• Registration Number: NCT00794365
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

The study will enroll smoking patients.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-11-19
• Study First Submitted QC: 2008-11-19
• Study First Posted: 2008-11-20
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2010-11
• Results First Submitted: 2010-11-19
• Results First Submitted QC: 2010-11-19
• Last Update Submitted: 2010-11-19
• Results First Posted: 2010-12-20
• Last Update Posted: 2010-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• Smoking adults aged ≥ 18 years intending to quit tobacco use who are prescribed Varenicline (Champix™) by their Physicians and those who are prescribed with Varenicline (Champix™) for the first time.

Exclusion Criteria

• Subjects in whom varenicline (Champix™) may be taken in a manner that is not according to the approved local product document.
• Pregnant or lactating women, or women of childbearing potential not using an acceptable method of contraception
• Subjects with known hypersensitivity to varenicline.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Open-label	Varenicline	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 4	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.
Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 8	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.
Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 12	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.