Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date

Smoking Cessation Clinical Trial

Official title:

A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00691483
• Other study ID #: A3051095
• Status: Completed
• Phase: Phase 4
• First received: June 3, 2008
• Last updated: October 16, 2015
• Start date: September 2008
• Est. completion date: December 2009

Study information

• Verified date: October 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 659
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Men and women

• 18 to 75 yrs old

• Motivated to stop smoking

• Smoke at least 10 cigarettes/day

Exclusion Criteria:

• Active psychiatric disease

• Severe or unstable cardiovascular or pulmonary disease

• Current or recent treatment to stop smoking

• Previous use of varenicline

Study Design

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• placebo
placebo tablet taken orally twice daily for 12 weeks
• varenicline
varenicline tablets, 1 mg taken orally twice daily for 12 weeks

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Buenos Aires
Brazil	Pfizer Investigational Site	Santo André	SP
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Quebec
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Guangzhou
China	Pfizer Investigational Site	Shenyang	Liaoning
Czech Republic	Pfizer Investigational Site	Brno
Czech Republic	Pfizer Investigational Site	Praha 2
France	Pfizer Investigational Site	Caen
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Goettingen
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Debrecen
Italy	Pfizer Investigational Site	Pisa
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Mexico	Pfizer Investigational Site	Monterrey	Nuevo Leon
Taiwan	Pfizer Investigational Site	Gwei Shan Township, Taoyuan County
Taiwan	Pfizer Investigational Site	Kaohsiung
United Kingdom	Pfizer Investigational Site	London
United States	Pfizer Investigational Site	Bridgeville	Pennsylvania
United States	Pfizer Investigational Site	Endwell	New York
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Litchfield Park	Arizona
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Milford	Massachusetts
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Santa Ana	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  China,  Czech Republic,  France,  Germany,  Hungary,  Italy,  Korea, Republic of,  Mexico,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in Fagerström Test for Nicotine Dependence (FTND) to Day of First Quit Attempt (FQA) Through Week 5 by Smoking Status at Weeks 9-12	Change in nicotine dependence from baseline to the date of the FQA within the first 5 weeks. FTND was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The FTND contains 4 yes-no and 2 multiple choice questions and can be used in a self-report format. The items on FTND are scored 0 to 3 for multiple choice items, the items are summed to yield a total score of 0-10 (0=minimum nicotine dependence; 10=maximum nicotine dependence).	Baseline through Week 5	No
Primary	Percentage of Participants With 4-week Continuous Abstinence (CA)	The percentage of participants who reported complete abstinence from cigarette smoking and other nicotine use (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) >10 parts per million (ppm) at any visits Week 9 through Week 12. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO >10 ppm.	Week 9 through Week 12	No
Secondary	Percentage of Participants With Continuous Abstinence (CA) From Smoking Weeks 9-24	Percentage of participants with CA from cigarette smoking and other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use, who did not have CO >10 ppm at any visits Week 9 through Week 24. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO >10 ppm.	Week 9 through Week 24	No
Secondary	Percentage of Participants With Long Term Quit Through Week 24	Responder for the primary endpoint of CA from Week 9 through Week 12 and who had no more than 6 days of smoking during the non-treatment phase of the study. For Weeks 13, 16, 20, and 24, long term quit was determined by CO-confirmed in-clinic visit.	Week 9 through Week 24	No
Secondary	Percentage of Participants With 7-day Point Prevalence of Nonsmoking (Smoking Cessation)	Percentage of participants with complete abstinence from cigarette smoking or other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use for the 7 days prior to Week 12 and Week 24, respectively, who did not have CO >10 ppm at any visits. CO-confirmed in-clinic visit.	Week 12 and Week 24	No
Secondary	Percentage of Participants With 4-week Point Prevalence of Nonsmoking	Percentage of participants with complete abstinence from cigarette smoking or use of tobacco products for the 4 weeks prior to Week 24 who did not have CO >10 ppm at any visits.	Week 24	No

External Links

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