Clinical trial NCT00669240: Varenicline Observational Investigation In The Cessation of Smoking
Official title: Champix Observational Investigation In The Cessation of Smoking
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking Cessation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-30
Enrollment: 567
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients enrolled should be of legal adult age who regularly smoke and of which the main tobacco product is cigarettes. The patients must be willing to make an attempt to stop smoking.

All patients enrolled should meet the usual prescribing criteria for varenicline as per SmPC and should be entered into the trial at the Investigators discretion.

Brief summary: The purpose of this study is to determine the safety and efficacy of varenicline in the real-world environment of smokers attending primary care in routine clinical practice with the addition of being offered behavioral support "Life REWARDS"TM. This is a non-interventional study.

Detailed description: Sampling Method Details: Patients as they come to surgeries for smoking cessation treatment.

Eligibility criteria: Inclusion Criteria:

* The patients enrolled should be of legal adult age who regularly smoke and of which the main tobacco product is cigarettes.
* The patients must be willing to make an attempt to stop smoking.

Exclusion Criteria:

* All patients enrolled should meet the usual prescribing criteria for varenicline as per SmPC and should be entered into the trial at the Investigators discretion.

Primary outcomes:
measure: Number of Participants With Non-serious Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline through Week 12 or Week 24
Secondary outcomes:
measure: Number of Participants Whose Smoking Status Was Known at the End of 12 Weeks
timeFrame: Week 12
measure: Number of Participants in Belgium Whose Smoking Status Was Known at the End of 12 Weeks and 24 Weeks
timeFrame: Week 12 and Week 24
measure: Number of Treatment Responders at Week 12
timeFrame: Week 12
measure: Number of Treatment Responders in Belgium at Week 12 and at Week 24
timeFrame: Week 12 and Week 24
measure: Number of Participants With Smoking Cessation Assessments at Weekly Intervals From Week 3 Through Week 11
timeFrame: Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11
measure: Number of Treatment Responders at Weekly Intervals From Week 3 Through Week 11
timeFrame: Weeks 3, 4, 5, 6, 7, 8, 9, 10, and 11
measure: Number of Participants for Whom a Maintenance Period of Varenicline Was Prescribed at the End of Week 12
timeFrame: Week 12
measure: Number of Participants Who Received Varenicline, by Duration of Treatment in Days
timeFrame: Baseline through Week 12 or Week 24
measure: Number of Participants Who Registered With LifeREWARDS On-line Behavioral Support Program
timeFrame: Week 12
measure: Minnesota Nicotine Withdrawal Scale (MNWS) Subscale Scores for Participants in Belgium
timeFrame: Week 7 and Week 13 or 14 (Week 13/14)
Other outcomes:
Locations:
city: Alleur
country: Belgium
facility: Pfizer Investigational Site
city: Beerse
country: Belgium
facility: Pfizer Investigational Site
city: Braine le Comte
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Deinze
country: Belgium
facility: Pfizer Investigational Site
city: Edegem
country: Belgium
facility: Pfizer Investigational Site
city: Genk
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Habay-la-Neuve
country: Belgium
facility: Pfizer Investigational Site
city: Halen
country: Belgium
facility: Pfizer Investigational Site
city: Jette
country: Belgium
facility: Pfizer Investigational Site
city: Kortessem
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Libramont-Chevigny
country: Belgium
facility: Pfizer Investigational Site
city: Liege
country: Belgium
facility: Pfizer Investigational Site
city: Moerkerke
country: Belgium
facility: Pfizer Investigational Site
city: Monceau-sur-Sambre
country: Belgium
facility: Pfizer Investigational Site
city: Moorsel
country: Belgium
facility: Pfizer Investigational Site
city: Namur
country: Belgium
facility: Pfizer Investigational Site
city: Rijkevorsel
country: Belgium
facility: Pfizer Investigational Site
city: Vedrin
country: Belgium
facility: Pfizer Investigational Site
city: Vilvoorde
country: Belgium
facility: Pfizer Investigational Site
city: Yvoir
country: Belgium
facility: Pfizer Investigational Site
city: Zedelgem
country: Belgium
facility: Pfizer Investigational Site
city: Holargos
country: Greece
facility: Pfizer Investigational Site
state: Athens
city: Ilisia
country: Greece
facility: Pfizer Investigational Site
state: Athens
city: Marousi
country: Greece
facility: Pfizer Investigational Site
state: Athens
city: Herakleion
country: Greece
facility: Pfizer Investigational Site
state: Crete
city: Exohi
country: Greece
facility: Pfizer Investigational Site
state: Thessaloniki
city: Alexandroupoli
country: Greece
facility: Pfizer Investigational Site
city: Ioannina
country: Greece
facility: Pfizer Investigational Site
city: Kavala
country: Greece
facility: Pfizer Investigational Site
city: Larissa
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Eger
country: Hungary
facility: Pfizer Investigational Site
city: Erd
country: Hungary
facility: Pfizer Investigational Site
city: Farkasgyepu
country: Hungary
facility: Pfizer Investigational Site
city: Hatvan
country: Hungary
facility: Pfizer Investigational Site
city: Nyiregyhaza
country: Hungary
facility: Pfizer Investigational Site
city: Siofok
country: Hungary
facility: Pfizer Investigational Site
city: Szombathely
country: Hungary
facility: Pfizer Investigational Site
city: Zalaegerszeg
country: Hungary
facility: Pfizer Investigational Site
city: Cerknica
country: Slovenia
facility: Pfizer Investigational Site
city: Domzale
country: Slovenia
facility: Pfizer Investigational Site
city: Jesenice
country: Slovenia
facility: Pfizer Investigational Site
city: Kranj
country: Slovenia
facility: Pfizer Investigational Site
city: Ljubljana
country: Slovenia
facility: Pfizer Investigational Site
city: Maribor
country: Slovenia
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Boudrez H, Hoengenaert JP, Nackaerts K, Messig M, Metcalfe M. Predictors of quit success in Belgian participants of a varenicline observational smoking cessation study. Acta Clin Belg. 2013 Jan-Feb;68(1):37-42. doi: 10.2143/ACB.68.1.2062718.
citation: Gratziou C, Gourgoulianis K, Pataka PA, Sykara GD, Messig M, Raju S. Varenicline as a smoking cessation aid in a Greek population: a subanalysis of an observational study. Tob Induc Dis. 2012 Feb 2;10(1):1. doi: 10.1186/1617-9625-10-1.
citation: Boudrez H, Gratziou C, Messig M, Metcalfe M. Effectiveness of varenicline as an aid to smoking cessation: results of an inter-European observational study. Curr Med Res Opin. 2011 Apr;27(4):769-75. doi: 10.1185/03007995.2011.557718. Epub 2011 Feb 4.