Smoking CessationPhase 2NCT00741884
A Study to Evaluate the Safety and Efficacy of Three Doses of a Controlled Release Formulation of Varenicline for Smoking Cessation
A Phase 2 study testing Varenicline Immediate Release 1 mg in people with Smoking Cessation, run by Pfizer.
Trial summary
The purpose of this study is to evaluate the safety, efficacy, and tolerability of twice daily (BID) administration of three dose strengths (1.2 mg, 1.8 mg, and 2.4 mg) of varenicline controlled release (CR) tablets in adult smokers. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Varenicline Immediate Release 1 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Aug 2011
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female cigarette smokers between the ages of 18 and 75 years, inclusive, who are motivated to stop smoking.
- Females of non-childbearing potential (surgically sterilized or at least 2 years postmenopausal) who are not nursing may be included.
- Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.
Who cannot join
- Subjects with clinically significant cardiovascular disease in the past 6 months.
- Subjects hospitalized within the past 12 months due to suicidal ideation or suicidal behavior or subjects considered to have serious suicidal ideation or suicidal behavior within the past 12 months.
- Subjects having active suicidal ideation or behavior identified at Screen or Baseline.
- Subjects currently or within the past 12 months requiring treatment for depression. Subjects with current or prior history of panic disorder, anxiety disorder, hostility or aggression disorder, perceptual/thinking disturbances, psychosis, or bipolar disorder.
About this study
Official title: A Phase 2, Seven Week, Double-Blind, Placebo Controlled, Randomized, Parallel Group Study To Evaluate The Safety And Efficacy Of Three Doses Of A Controlled Release Formulation Of Varenicline For Smoking Cessation
The purpose of this study is to evaluate the safety, efficacy, and tolerability of twice daily (BID) administration of three dose strengths (1.2 mg, 1.8 mg, and 2.4 mg) of varenicline controlled release (CR) tablets in adult smokers.
- Conditions
- Smoking Cessation
- Being tested
- Varenicline Controlled Release 1.2 mg, Varenicline Controlled Release 1.8 mg, Varenicline Controlled Release 2.4 mg, Varenicline Immediate Release 1 mg, Placebo
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varenicline Controlled Release 1.2 mgDrug
Varenicline CR tablet 1.2 mg BID for 7 weeks
Varenicline Controlled Release 1.8 mgDrug
Varenicline CR tablet 1.8 mg BID for 7 weeks
Varenicline Controlled Release 2.4 mgDrug
Varenicline CR tablet 2.4 mg BID for 7 weeks
Varenicline Immediate Release 1 mgDrug
Varenicline IR tablet 1 mg BID for 7 weeks
PlaceboDrug
Placebo BID for 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Varenicline Controlled Release 1.2 mg |
| Arm 2 | Experimental | Not described Receives: Drug: Varenicline Controlled Release 1.8 mg |
| Arm 3 | Experimental | Not described Receives: Drug: Varenicline Controlled Release 2.4 mg |
| Arm 4 | Active comparator | Not described Receives: Drug: Varenicline Immediate Release 1 mg |
| Arm 5 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous abstinence from smoking for weeks 4-7, carbon monoxide confirmed
Measured: 7 weeks
Secondary outcomes (5)
7- day point prevalence of non-smoking at week 7
Measured: 7 days
Scores on the Minnesota Nicotine Withdrawal Scale subscales
Measured: 7 weeks
Scores on the Modified Cigarette Evaluation Questionaire subscales
Measured: 7 weeks
PK analysis
Measured: 7 weeks
Safety Assessments: adverse events, C-SSRs, vital signs, body weight
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startAug 2010
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 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
- NCT00741884
- Sponsor's protocol ID
- A3051090
- Status last verified
- Apr 2015
- First submitted
- 22 Aug 2008
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Seven Week, Double-Blind, Placebo Controlled, Randomized, Parallel Group Study To Evaluate The Safety And Efficacy Of Three Doses Of A Controlled Release Formulation Of Varenicline For Smoking Cessation
- ClinicalTrials.gov ID
- NCT00741884
- Acronym / sponsor ID
- A3051090
- Conditions
- Smoking Cessation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 26 Aug 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 safety, efficacy, and tolerability of twice daily (BID) administration of three dose strengths (1.2 mg, 1.8 mg, and 2.4 mg) of varenicline controlled release (CR) tablets in adult smokers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Varenicline Controlled Release 1.2 mg |
| Arm 2 | Experimental | Drug: Varenicline Controlled Release 1.8 mg |
| Arm 3 | Experimental | Drug: Varenicline Controlled Release 2.4 mg |
| Arm 4 | Active comparator | Drug: Varenicline Immediate Release 1 mg |
| Arm 5 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female cigarette smokers between the ages of 18 and 75 years, inclusive, who are motivated to stop smoking.
- Females of non-childbearing potential (surgically sterilized or at least 2 years postmenopausal) who are not nursing may be included.
- Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.
Key exclusion criteria (4 listed)
- Subjects with clinically significant cardiovascular disease in the past 6 months.
- Subjects hospitalized within the past 12 months due to suicidal ideation or suicidal behavior or subjects considered to have serious suicidal ideation or suicidal behavior within the past 12 months.
- Subjects having active suicidal ideation or behavior identified at Screen or Baseline.
- Subjects currently or within the past 12 months requiring treatment for depression. Subjects with current or prior history of panic disorder, anxiety disorder, hostility or aggression disorder, perceptual/thinking disturbances, psychosis, or bipolar disorder.
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 |
|---|---|---|
| Varenicline Controlled Release 1.2 mgVarenicline CR tablet 1.2 mg BID for 7 weeks | Drug | Arm 1 |
| Varenicline Controlled Release 1.8 mgVarenicline CR tablet 1.8 mg BID for 7 weeks | Drug | Arm 2 |
| Varenicline Controlled Release 2.4 mgVarenicline CR tablet 2.4 mg BID for 7 weeks | Drug | Arm 3 |
| Varenicline Immediate Release 1 mgVarenicline IR tablet 1 mg BID for 7 weeks | Drug | Arm 4 |
| PlaceboPlacebo BID for 7 weeks | Drug | Arm 5 |
Primary outcome
Continuous abstinence from smoking for weeks 4-7, carbon monoxide confirmed
Time frame: 7 weeks
5 secondary outcomes
7- day point prevalence of non-smoking at week 7
Time frame: 7 days
Scores on the Minnesota Nicotine Withdrawal Scale subscales
Time frame: 7 weeks
Scores on the Modified Cigarette Evaluation Questionaire subscales
Time frame: 7 weeks
PK analysis
Time frame: 7 weeks
Safety Assessments: adverse events, C-SSRs, vital signs, body weight
Time frame: 7 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Varenicline Immediate Release 1 mg in people with Smoking Cessation, run by Pfizer.
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 4 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: withdrawn, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Continuous abstinence from smoking for weeks 4-7, carbon monoxide confirmed (time frame: 7 weeks). 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 22 Apr 2015.