SmokingPhase 2NCT00635401
A Study of the Efficacy and Safety of Varenicline in Japanese Smokers Motivated to Quit Smoking
A Phase 2 study testing Varenicline in people with Smoking, run by Pfizer at 8 sites in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of varenicline in Japanese smokers. Efficacy is evaluated by continuous quit rate and withdrawal symptoms of smokers. Safety is evaluated by adverse events, laboratory tests, and other safety tests. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Smoking
- What is being tested?
- Varenicline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 8 sitesJapan
- Study dates
- May 2004to Aug 2004
- 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
- Japanese smokers motivated to quit smoking
- No period without smoking of more than 3 months
- Smoked an average of at least 10 cigarettes/day in the past year
Who cannot join
- Subjects who have used nicotine replacement therapy within 1 month of the study screening visit
- Subjects intending to use nicotine replacement therapy or other smoking cessation treatments during the study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Pfizer Investigational Site
Beppu, Oita Prefecture
Pfizer Investigational Site
Chuo-ku Fukuoka, Fukuoka
Pfizer Investigational Site
Edogawa-ku, Tokyo
Pfizer Investigational Site
Hamamatsu, Shizuoka
Pfizer Investigational Site
Minato-ku, Tokyo
Pfizer Investigational Site
Nishi-ku Yokohama, Kanagawa
Pfizer Investigational Site
Ōita, Oita Prefecture
Pfizer Investigational Site
Toshima-ku, Tokyo
About this study
Official title: A Multicenter, Open-Label Study Exploring the Efficacy and Safety of Varenicline in Japanese Smokers Motivated to Quit Smoking
The purpose of this study is to evaluate the efficacy and safety of varenicline in Japanese smokers. Efficacy is evaluated by continuous quit rate and withdrawal symptoms of smokers. Safety is evaluated by adverse events, laboratory tests, and other safety tests.
- Conditions
- Smoking
- Being tested
- Varenicline
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Chantix, Champix, CP-526,555
0.5 mg BID for 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| 0.5 mg BID | Experimental | Not described Receives: Drug: Varenicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carbon monoxide (CO)-confirmed 4-week continuous quit rate (4-week CQR) from Weeks 4 to 7.
Measured: Weeks 4-7
Secondary outcomes (8)
CO-confirmed 7-day Point Prevalence from Week 2 through Week 7.
Measured: Weeks 2-7
Continuous abstinence rate from target quit date (TQD) from Week 2 through Week 7.
Measured: Weeks 2-7
Average number of daily cigarettes smoked from Week 2 through Week 7.
Measured: Weeks 2-7
Assessment of withdrawal symptoms by Minnesota Nicotine Withdrawal Scales (MNWS) from Week 2 through Week 7.
Measured: Weeks 2-7
Assessment of satisfaction (desirable and aversive effects) obtained from smoking by Smoking Effects Inventory (SEI) (administered only to subjects who had smoked since the previous assessment) from Week 2 through Week 7.
Measured: Weeks 2-7
Assessment of tobacco craving by the Brief Questionnaire of Smoking Urges (QSU-Brief) from Week 2 through Week 7.
Measured: Weeks 2-7
Assessment of the effect of smoking cessation on subjects' quality of life by the Smoking Cessation Quality of Life (SCQoL) questionnaire from Week 2 through Week 7.
Measured: Weeks 2-7
Adverse events, laboratory test changes throughout the study.
Measured: Weeks 1-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startMay 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
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
- NCT00635401
- Sponsor's protocol ID
- A3051043
- Status last verified
- Apr 2008
- First submitted
- 5 Mar 2008
- Last updated
- 10 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Study Exploring the Efficacy and Safety of Varenicline in Japanese Smokers Motivated to Quit Smoking
- ClinicalTrials.gov ID
- NCT00635401
- Acronym / sponsor ID
- A3051043
- Conditions
- Smoking
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Study completion
- Aug 2004 (actual)
- First posted
- 13 Mar 2008 (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 this study is to evaluate the efficacy and safety of varenicline in Japanese smokers. Efficacy is evaluated by continuous quit rate and withdrawal symptoms of smokers. Safety is evaluated by adverse events, laboratory tests, and other safety tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 0.5 mg BID | Experimental | Drug: Varenicline |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Japanese smokers motivated to quit smoking
- No period without smoking of more than 3 months
- Smoked an average of at least 10 cigarettes/day in the past year
Key exclusion criteria (2 listed)
- Subjects who have used nicotine replacement therapy within 1 month of the study screening visit
- Subjects intending to use nicotine replacement therapy or other smoking cessation treatments 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 |
|---|---|---|
| VareniclineAlso: Chantix, Champix, CP-526,5550.5 mg BID for 7 weeks | Drug | 0.5 mg BID |
Primary outcome
Carbon monoxide (CO)-confirmed 4-week continuous quit rate (4-week CQR) from Weeks 4 to 7.
Time frame: Weeks 4-7
8 secondary outcomes
CO-confirmed 7-day Point Prevalence from Week 2 through Week 7.
Time frame: Weeks 2-7
Continuous abstinence rate from target quit date (TQD) from Week 2 through Week 7.
Time frame: Weeks 2-7
Average number of daily cigarettes smoked from Week 2 through Week 7.
Time frame: Weeks 2-7
Assessment of withdrawal symptoms by Minnesota Nicotine Withdrawal Scales (MNWS) from Week 2 through Week 7.
Time frame: Weeks 2-7
Assessment of satisfaction (desirable and aversive effects) obtained from smoking by Smoking Effects Inventory (SEI) (administered only to subjects who had smoked since the previous assessment) from Week 2 through Week 7.
Time frame: Weeks 2-7
Assessment of tobacco craving by the Brief Questionnaire of Smoking Urges (QSU-Brief) from Week 2 through Week 7.
Time frame: Weeks 2-7
Assessment of the effect of smoking cessation on subjects' quality of life by the Smoking Cessation Quality of Life (SCQoL) questionnaire from Week 2 through Week 7.
Time frame: Weeks 2-7
Adverse events, laboratory test changes throughout the study.
Time frame: Weeks 1-7
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 10 Apr 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
8 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 Varenicline in people with Smoking, run by Pfizer at 8 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 3 inclusion and 2 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 10 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Carbon monoxide (CO)-confirmed 4-week continuous quit rate (4-week CQR) from Weeks 4 to 7. (time frame: Weeks 4-7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2008.