Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01244061
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01244061
Recruitment Status : Completed
First Posted : November 19, 2010
Results First Posted : June 9, 2014
Last Update Posted : June 9, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 17, 2010
First Posted Date  ICMJE November 19, 2010
Results First Submitted Date  ICMJE October 30, 2013
Results First Posted Date  ICMJE June 9, 2014
Last Update Posted Date June 9, 2014
Study Start Date  ICMJE December 2010
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
Continuous Abstinence Rate (CAR) From Week 9 Through Week 12 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2010)
Continuous Abstinence Rate for Weeks 9-12 (CAR 9-12) [ Time Frame: Weeks 9-12 ]
Change History Complete list of historical versions of study NCT01244061 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
  • CAR From Week 9 Through Week 52 [ Time Frame: 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.
  • CAR From Week 9 Through Week 24 [ Time Frame: 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.
  • 7-day Point Prevalence (PP) of Abstinence at Weeks 12, 24, and 52 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2010)
  • Continuous Abstinence Rate Weeks 9-52 (CAR 9-52) [ Time Frame: Weeks 9-52 ]
  • Continuous Abstinence Rate Weeks 9-24 (CAR 9-24) [ Time Frame: Weeks 9-24 ]
  • 7 day point prevalence of smoking cessation at Weeks 12, 24 and 52 [ Time Frame: Weeks 12, 24 and 52 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Drug: Varenicline
    Varenicline 1mg twice daily
  • Drug: Placebo
    Matched placebo twice daily
Study Arms  ICMJE
  • Experimental: Varenicline
    Intervention: Drug: Varenicline
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2013)
498
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2010)
490
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Czech Republic,   France,   Germany,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01244061
Other Study ID Numbers  ICMJE A3051139
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP