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

Smoking Cessation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244061
• Other study ID #: A3051139
• Status: Completed
• Phase: Phase 4
• First received: November 17, 2010
• Last updated: May 20, 2014
• Start date: December 2010
• Est. completion date: November 2012

Study information

• Verified date: May 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 498
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Varenicline
Varenicline 1mg twice daily
• Placebo
Matched placebo twice daily

Locations

Country	Name	City	State
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Emeritus Research	Malvern	Victoria
Australia	Australian Clinical Research Network	Maroubra	New South Wales
Australia	AusTrials Australia	Sherwood	Queensland
Belgium	Universitair Ziekenhuis Antwerpen, Afdeling Pneumologie	Edegem
Belgium	Universitaire Ziekenhuizen Leuven/Pneumologie	Leuven
Belgium	Centre Hospitalier Universitaire de Liege	Liege
Belgium	Cliniques Universitaires U.C.L. de Mont-Godinne/Laboratoire	Yvoir
Canada	Office of Dr. Ronald Collette	Burnaby	British Columbia
Canada	Clinique des maladies Lipidiques de Quebec	Quebec
Canada	White Hills Medical Clinic	St. John's	Newfoundland and Labrador
Canada	Canadian Phase Onward Inc.	Toronto	Ontario
Czech Republic	Fakultni nemocnice Brno	Brno
Czech Republic	Krajska nemocnice Liberec a.s., Plicni oddeleni	Liberec 1
Czech Republic	Mestska nemocnice Ostrava, Plicni oddeleni	Ostrava 1
Czech Republic	Vseobecna fakultni nemocnice v Praze	Praha 2
France	CHU de la Cavale Blanche	Brest
France	CHU Côte de Nacre, Unité de Coordination de Tabacologie	Caen
France	Hopital Arnaud de Villeneuve	Montpellier Cedex 5
Germany	Klinische Forschung Berlin	Berlin
Germany	Universitaetsklinikum Goettingen Zentrum Innere Medizin Abteilung Kardiologie und Pneumologie	Goettingen
Germany	Klinische Forschung Hamburg GmbH	Hamburg
Germany	Ludwig Maximilians-Universitaet Muenchen	Muenchen
Germany	FOCUS Clinical Drug Development GmbH	Neuss
United Kingdom	Synexus Lancashire Clinical Research Centre	Chorley	Lancashire
United Kingdom	Synexus Scotland Clinical Research Centre	Glasgow
United Kingdom	Synexus, Merseyside Clinical Research Centre	Liverpool
United Kingdom	William Harvey Research Institute,	London
United Kingdom	Synexus Thames Valley Clinical Research Centre	Reading	Berks
United States	The University of Maryland	College Park	Maryland
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	The Center for Pharmaceutical Research, PC	Kansas City	Missouri
United States	Central Kentucky Research Associates, Inc.	Lexington	Kentucky
United States	Ronald Reagan University of California Los Angeles Medical Center	Los Angeles	California
United States	University of California Los Angeles David Geffen School of Medicine	Los Angeles	California
United States	Clinical Research Associates, Inc.	Nashville	Tennessee
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czech Republic,  France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous Abstinence Rate (CAR) From Week 9 Through Week 12	The percentage of participants who, from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO)> 10ppm at any visits during this time frame.	Week 9 through Week 12	No
Secondary	CAR From Week 9 Through Week 52	The percentage of participants who, from Week 9 through Week 52, reported no smoking (Weeks 9 through 52) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 52), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO >10 ppm at any of these visits during this time frame.	Week 9 through Week 52	No
Secondary	CAR From Week 9 Through Week 24	The percentage of participants who, from Week 9 through Week 24, reported no smoking (Weeks 9 through 24) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 24), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO >10 ppm at any of these visits during this time frame.	Week 9 through Week 24	No
Secondary	7-day Point Prevalence (PP) of Abstinence at Weeks 12, 24, and 52	The secondary endpoint of 7-day point prevalence of smoking cessation was determined by evaluating a participant's cigarette smoking status, and other nicotine (and/or other tobacco) use, based on the "last 7 days" questions in the Nicotine Use Inventory. Additionally, a participant was not considered a responder if the expired CO was >10 ppm at the time point being summarized. Participants were considered responders independently at each visit.	Weeks 12, 24 and 52	No

External Links

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