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

Smoking Cessation Clinical Trial

Official title:

Post-Marketing Surveillance Study To Observe The Safety And Effectiveness Of Varenicline (Champix) Tablets In Smoking Cessation Among Filipino Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00794365
• Other study ID #: A3051079
• Status: Completed
• Phase: N/A
• First received: November 19, 2008
• Last updated: November 19, 2010
• Start date: July 2008
• Est. completion date: November 2009

Study information

• Verified date: November 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Bureau of Food and Drugs
• Study type: Observational

Clinical Trial 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

Description:

The study will enroll smoking patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Varenicline
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 4	No
Primary	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.	Week 8	No
Primary	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.	Week 12	No

External Links

•   To obtain contact information for a study center near you, click here.