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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01244061
Registration number
NCT01244061
Ethics application status
Date submitted
17/11/2010
Date registered
19/11/2010
Date last updated
9/06/2014
Titles & IDs
Public title
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
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Scientific 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
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Secondary ID [1]
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A3051139
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Varenicline
Treatment: Drugs - Placebo
Experimental: Varenicline -
Placebo comparator: Placebo -
Treatment: Drugs: Varenicline
Varenicline 1mg twice daily
Treatment: Drugs: Placebo
Matched placebo twice daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Continuous Abstinence Rate (CAR) From Week 9 Through Week 12
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Assessment method [1]
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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.
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Timepoint [1]
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Week 9 through Week 12
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Secondary outcome [1]
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CAR From Week 9 Through Week 52
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Assessment method [1]
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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.
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Timepoint [1]
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Week 9 through Week 52
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Secondary outcome [2]
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CAR From Week 9 Through Week 24
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Assessment method [2]
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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.
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Timepoint [2]
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Week 9 through Week 24
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Secondary outcome [3]
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7-day Point Prevalence (PP) of Abstinence at Weeks 12, 24, and 52
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Assessment method [3]
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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.
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Timepoint [3]
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Weeks 12, 24 and 52
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2012
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Sample size
Target
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Accrual to date
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Final
498
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Australian Clinical Research Network - Maroubra
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Recruitment hospital [2]
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Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [3]
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AusTrials Australia - Sherwood
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Recruitment hospital [4]
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Emeritus Research - Malvern
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Recruitment postcode(s) [1]
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2035 - Maroubra
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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4075 - Sherwood
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Recruitment postcode(s) [4]
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3145 - Malvern
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Recruitment outside Australia
Country [1]
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United States of America
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California
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United States of America
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Florida
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Kentucky
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Maryland
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Missouri
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Tennessee
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Edegem
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Belgium
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Belgium
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Belgium
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Yvoir
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British Columbia
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Canada
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Newfoundland and Labrador
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Canada
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Ontario
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Canada
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Quebec
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Brno
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Czech Republic
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Liberec 1
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Czech Republic
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Ostrava 1
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Czech Republic
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Praha 2
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France
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Brest
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France
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Caen
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France
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Montpellier Cedex 5
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Germany
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Berlin
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Germany
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Goettingen
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Germany
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Hamburg
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Germany
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Muenchen
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Germany
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Neuss
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United Kingdom
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Berks
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United Kingdom
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Lancashire
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United Kingdom
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Glasgow
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United Kingdom
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Liverpool
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT01244061
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Phone
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01244061
Download to PDF