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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00794365
First received: November 19, 2008
Last updated: November 19, 2010
Last verified: November 2010

November 19, 2008
November 19, 2010
July 2008
November 2009   (final data collection date for primary outcome measure)
  • Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.
Safety will be based on reported and observed adverse events. [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00794365 on ClinicalTrials.gov Archive Site
Not Provided
  • Data on effectiveness of Varenicline in smoking cessation will also be collected on enrolled subjects using the Nicotine Use Inventory (NUI). [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Fagerstrom Test for Nicotine Dependence (FTND) will also be used for measuring nicotine dependence at baseline. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Post Marketing Surveillance Study of Champix in Smoking Cessation for Filipino Patients
Post-Marketing Surveillance Study To Observe The Safety And Effectiveness Of Varenicline (Champix) Tablets In Smoking Cessation Among Filipino Subjects

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

This post-marketing surveillance study will be conducted nationwide and will enroll approximately 3,000 study patients. Subject enrollment of less than 3,000 will be acceptable in case of less than expected use of Varenicline (Champix™) by physicians.

Smoking Cessation
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.

Other Name: Chantix, Champix
Open-label
Intervention: Drug: Varenicline
Park PW, Casiano EM, Escoto L, Claveria AM. Observational study of safety and efficacy of varenicline for smoking cessation among Filipino smokers. Curr Med Res Opin. 2011 Oct;27(10):1869-75. Epub 2011 Aug 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
330
November 2009
November 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00794365
A3051079
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP