Smoking CessationPhase 2NCT00139750
12 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking Cessation
A Phase 2 study testing CP-526,555 (varenicline) in people with Smoking Cessation, run by Pfizer at 15 sites in Japan.
Trial summary
The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- CP-526,555 (varenicline)
- How many people
- 600 participants
- Where
- 15 sitesJapan
- Study dates
- Dec 2004to Feb 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cigarette smokers who are motivated to stop smoking and have smoked an average of at least 10 cigarettes per day
Who cannot join
- Subjects who have used a nicotine replacement product within 30 days of the study screening visit or intend to use it during the study.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Japan15 sites
Pfizer Investigational Site
Beppu-shi, Oita Prefecture
Pfizer Investigational Site
Edogawa-ku, Tokyo
Pfizer Investigational Site
Fukuoka, Fukuoka
Pfizer Investigational Site
Hamamatsu, Shizuoka
Pfizer Investigational Site
Minato-ku, Tokyo
Pfizer Investigational Site
Musashino, Tokyo
Pfizer Investigational Site
Noda, Chiba
Pfizer Investigational Site
Ohita, Ohita
Pfizer Investigational Site
Sapporo, Hokkaido
Pfizer Investigational Site
Setagaya-ku, Tokyo
Pfizer Investigational Site
Shinagawa-ku, Tokyo
Pfizer Investigational Site
Toshima-ku, Tokyo
Pfizer Investigational Site
Tosu, Saga-ken
Pfizer Investigational Site
Toyonaka, Osaka
Pfizer Investigational Site
Yokohama, Kanagawa
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of CP-526,555 In Smokers Motivated To Stop Smoking
The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. A small satellite protocol (A3051048) investigated safety of a second course of therapy in subjects who did not quit.
- Conditions
- Smoking Cessation
- Being tested
- CP-526,555 (varenicline)
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-526,555 (varenicline)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
4-week continuous quit rate (CQR) for Weeks 9-12
Secondary outcomes (9)
Continuous abstinence for Weeks 9-52 and Weeks 9-24
Long-term quit rate at Week 52
4-week CQR for Weeks 4-7
7-day point prevalence of asbtinence Weeks 12, Week 24, and Week 52
Continuous abstinence from TQD (Week 1) through Week 12
Weekly average number of cigarettes smoked per day for Weeks 1-12
Evaluation of withdrawal symptoms by the Minnesota Nicotine Withdrawal Scale
Evaluation of smoking satisfaction by the Smoking Effects Inventory
Evaluation of urge to smoke by the Brief Questionnaire of Smoking Urges
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startDec 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139750
- Sponsor's protocol ID
- A3051046
- Status last verified
- Jun 2007
- First submitted
- 29 Aug 2005
- Last updated
- 4 Jun 2007
- Results posted
- No
Publications
Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PubMed 37142273Nakamura M, Oshima A, Ohkura M, Arteaga C, Suwa K. Predictors of lapse and relapse to smoking in successful quitters in a varenicline post hoc analysis in Japanese smokers. Clin Ther. 2014 Jun 1;36(6):918-27. doi: 10.1016/j.clinthera.2014.03.013. Epub 2014 May 5.
PubMed 24811751Nakamura M, Oshima A, Fujimoto Y, Maruyama N, Ishibashi T, Reeves KR. Efficacy and tolerability of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, in a 12-week, randomized, placebo-controlled, dose-response study with 40-week follow-up for smoking cessation in Japanese smokers. Clin Ther. 2007 Jun;29(6):1040-56. doi: 10.1016/j.clinthera.2007.06.012.
PubMed 17692720
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of CP-526,555 In Smokers Motivated To Stop Smoking
- ClinicalTrials.gov ID
- NCT00139750
- Acronym / sponsor ID
- A3051046
- Conditions
- Smoking Cessation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Study completion
- Feb 2006 (actual)
- First posted
- 31 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. A small satellite protocol (A3051048) investigated safety of a second course of therapy in subjects who did not quit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cigarette smokers who are motivated to stop smoking and have smoked an average of at least 10 cigarettes per day
Key exclusion criteria (1 listed)
- Subjects who have used a nicotine replacement product within 30 days of the study screening visit or intend to use it during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CP-526,555 (varenicline) | Drug | – |
Primary outcome
4-week continuous quit rate (CQR) for Weeks 9-12
9 secondary outcomes
Continuous abstinence for Weeks 9-52 and Weeks 9-24
Long-term quit rate at Week 52
4-week CQR for Weeks 4-7
7-day point prevalence of asbtinence Weeks 12, Week 24, and Week 52
Continuous abstinence from TQD (Week 1) through Week 12
Weekly average number of cigarettes smoked per day for Weeks 1-12
Evaluation of withdrawal symptoms by the Minnesota Nicotine Withdrawal Scale
Evaluation of smoking satisfaction by the Smoking Effects Inventory
Evaluation of urge to smoke by the Brief Questionnaire of Smoking Urges
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2007.
- Derived from this study: PubMed 37142273Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
- Derived from this study: PubMed 24811751Nakamura M, Oshima A, Ohkura M, Arteaga C, Suwa K. Predictors of lapse and relapse to smoking in successful quitters in a varenicline post hoc analysis in Japanese smokers. Clin Ther. 2014 Jun 1;36(6):918-27. doi: 10.1016/j.clinthera.2014.03.013. Epub 2014 May 5.
- Derived from this study: PubMed 17692720Nakamura M, Oshima A, Fujimoto Y, Maruyama N, Ishibashi T, Reeves KR. Efficacy and tolerability of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, in a 12-week, randomized, placebo-controlled, dose-response study with 40-week follow-up for smoking cessation in Japanese smokers. Clin Ther. 2007 Jun;29(6):1040-56. doi: 10.1016/j.clinthera.2007.06.012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CP-526,555 (varenicline) in people with Smoking Cessation, run by Pfizer at 15 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4-week continuous quit rate (CQR) for Weeks 9-12. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00139750, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2007.