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Trial record 1 of 1 for:    NCT00794365
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Post Marketing Surveillance Study of Champix in Smoking Cessation for Filipino Patients

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ClinicalTrials.gov Identifier: NCT00794365
Recruitment Status : Completed
First Posted : November 20, 2008
Results First Posted : December 20, 2010
Last Update Posted : December 20, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date November 19, 2008
First Posted Date November 20, 2008
Results First Submitted Date November 19, 2010
Results First Posted Date December 20, 2010
Last Update Posted Date December 20, 2010
Study Start Date July 2008
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 19, 2010)
  • Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 4 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures
 (submitted: November 19, 2008)
Safety will be based on reported and observed adverse events. [ Time Frame: week 12 ]
Change History Complete list of historical versions of study NCT00794365 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: November 19, 2008)
  • 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 ]
  • Fagerstrom Test for Nicotine Dependence (FTND) will also be used for measuring nicotine dependence at baseline. [ Time Frame: Week 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post Marketing Surveillance Study of Champix in Smoking Cessation for Filipino Patients
Official Title Post-Marketing Surveillance Study To Observe The Safety And Effectiveness Of Varenicline (Champix) Tablets In Smoking Cessation Among Filipino Subjects
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition 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.

Other Name: Chantix, Champix
Study Groups/Cohorts Open-label
Intervention: Drug: Varenicline
Publications * 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. doi: 10.1185/03007995.2011.607436. Epub 2011 Aug 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 2, 2010)
330
Original Estimated Enrollment
 (submitted: November 19, 2008)
3000
Actual Study Completion Date November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00794365
Other Study ID Numbers A3051079
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2010