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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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
Secondary ID [1] 0 0
A3051139
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Week 9 through Week 12
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Week 9 through Week 52
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Week 9 through Week 24
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Weeks 12, 24 and 52

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Australian Clinical Research Network - Maroubra
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [3] 0 0
AusTrials Australia - Sherwood
Recruitment hospital [4] 0 0
Emeritus Research - Malvern
Recruitment postcode(s) [1] 0 0
2035 - Maroubra
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
4075 - Sherwood
Recruitment postcode(s) [4] 0 0
3145 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
Belgium
State/province [8] 0 0
Edegem
Country [9] 0 0
Belgium
State/province [9] 0 0
Leuven
Country [10] 0 0
Belgium
State/province [10] 0 0
Liege
Country [11] 0 0
Belgium
State/province [11] 0 0
Yvoir
Country [12] 0 0
Canada
State/province [12] 0 0
British Columbia
Country [13] 0 0
Canada
State/province [13] 0 0
Newfoundland and Labrador
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Brno
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Liberec 1
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Ostrava 1
Country [19] 0 0
Czech Republic
State/province [19] 0 0
Praha 2
Country [20] 0 0
France
State/province [20] 0 0
Brest
Country [21] 0 0
France
State/province [21] 0 0
Caen
Country [22] 0 0
France
State/province [22] 0 0
Montpellier Cedex 5
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Goettingen
Country [25] 0 0
Germany
State/province [25] 0 0
Hamburg
Country [26] 0 0
Germany
State/province [26] 0 0
Muenchen
Country [27] 0 0
Germany
State/province [27] 0 0
Neuss
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Berks
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Lancashire
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Glasgow
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Liverpool
Country [32] 0 0
United Kingdom
State/province [32] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/show/NCT01244061
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications