Clinical trial NCT01244061: A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider
Official title: A Phase 4 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Re-Treatment With Varenicline In Subjects Who Are Currently Smoking, And Who Have Previously Taken Varenicline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-11-19
Enrollment: 498
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain abstinent at Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of treatment).


Eligibility criteria: Inclusion Criteria:

* Smokers aged 18 years or above and wanting to stop smoking
* Smokers who have smoked an average of at least 10 cigarettes per day over the last 4 weeks
* Smokers who have tried before to stop smoking at least once with varenicline, and who took varenicline for at least 2 weeks
* The last attempt to stop smoking must be at least 3 months before entering the study

Exclusion Criteria:

* Individuals who have not tolerated varenicline well previously, or who have a current or prior medical or psychiatric history that would make entry into the trial inadvisable
* Individuals who have previously participated in clinical trials of varenicline
* Individuals who have been participating in another smoking cessation trial within the last 3 months, or other drug trial within the last 30 days

Primary outcomes:
measure: Continuous Abstinence Rate (CAR) From Week 9 Through Week 12
timeFrame: Week 9 through Week 12
Secondary outcomes:
measure: CAR From Week 9 Through Week 52
timeFrame: Week 9 through Week 52
measure: CAR From Week 9 Through Week 24
timeFrame: Week 9 through Week 24
measure: 7-day Point Prevalence (PP) of Abstinence at Weeks 12, 24, and 52
timeFrame: Weeks 12, 24 and 52
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan University of California Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles David Geffen School of Medicine
state: California
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Lexington
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
city: College Park
country: United States
facility: The University of Maryland
state: Maryland
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research, PC
state: Missouri
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Maroubra
country: Australia
facility: Australian Clinical Research Network
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Sherwood
country: Australia
facility: AusTrials Australia
state: Queensland
city: Malvern
country: Australia
facility: Emeritus Research
state: Victoria
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen, Afdeling Pneumologie
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven/Pneumologie
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege
city: Yvoir
country: Belgium
facility: Cliniques Universitaires U.C.L. de Mont-Godinne/Laboratoire
city: Burnaby
country: Canada
facility: Office of Dr. Ronald Collette
state: British Columbia
city: St. John's
country: Canada
facility: White Hills Medical Clinic
state: Newfoundland and Labrador
city: Toronto
country: Canada
facility: Canadian Phase Onward Inc.
state: Ontario
city: Quebec
country: Canada
facility: Clinique des maladies Lipidiques de Quebec
city: Brno
country: Czech Republic
facility: Fakultni nemocnice Brno
city: Liberec 1
country: Czech Republic
facility: Krajska nemocnice Liberec a.s., Plicni oddeleni
city: Ostrava 1
country: Czech Republic
facility: Mestska nemocnice Ostrava, Plicni oddeleni
city: Praha 2
country: Czech Republic
facility: Vseobecna fakultni nemocnice v Praze
city: Brest
country: France
facility: CHU de la Cavale Blanche
city: Caen
country: France
facility: CHU Côte de Nacre, Unité de Coordination de Tabacologie
city: Montpellier Cedex 5
country: France
facility: Hopital Arnaud de Villeneuve
city: Berlin
country: Germany
facility: Klinische Forschung Berlin
city: Goettingen
country: Germany
facility: Universitaetsklinikum Goettingen Zentrum Innere Medizin Abteilung Kardiologie und Pneumologie
city: Hamburg
country: Germany
facility: Klinische Forschung Hamburg GmbH
city: Muenchen
country: Germany
facility: Ludwig Maximilians-Universitaet Muenchen
city: Neuss
country: Germany
facility: FOCUS Clinical Drug Development GmbH
city: Reading
country: United Kingdom
facility: Synexus Thames Valley Clinical Research Centre
state: Berks
city: Chorley
country: United Kingdom
facility: Synexus Lancashire Clinical Research Centre
state: Lancashire
city: Glasgow
country: United Kingdom
facility: Synexus Scotland Clinical Research Centre
city: Liverpool
country: United Kingdom
facility: Synexus, Merseyside Clinical Research Centre
city: London
country: United Kingdom
facility: William Harvey Research Institute,
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Gonzales D, Hajek P, Pliamm L, Nackaerts K, Tseng LJ, McRae TD, Treadow J. Retreatment with varenicline for smoking cessation in smokers who have previously taken varenicline: a randomized, placebo-controlled trial. Clin Pharmacol Ther. 2014 Sep;96(3):390-6. doi: 10.1038/clpt.2014.124. Epub 2014 Jun 9.