NCT00794365 - Post Marketing Surveillance Study of Champix in Smoking Cessation for Filipino Patients | Crick

Overview

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

The study will enroll smoking patients.

Study Type

OBSERVATIONAL

Enrollment

330

Conditions

Smoking Cessation

Interventions

VareniclineDRUG

There are two packs available for Varenicline (Champix™). 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 (Champix™) 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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Week 12