Drug Use Investigation Of Varenicline (Regulatory Post Marketing Commitment Plan)

An observational study of Smoking Cessation, run by Pfizer.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug. Read more about this study

Who is it for?: Any age
Conditions the study is for: Smoking Cessation
What is being tested?: Varenicline
Type of treatment: Pill or oral medicine
How many people: 3,939 participants
Where: No sites listed yet
Study dates: Feb 2009to Dec 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: The patients whom an investigator involving A3051109 prescribes the Varenicline(Champix).

Who may be able to join

Patients need to be administered Varenicline(Champix) in order to be enrolled in the surveillance.

Who cannot join

Patients not administered Varenicline(Champix).

About this study

Official title: Drug Use Investigation Of Champix (Regulatory Post Marketing Commitment Plan)

Read the detailed description

All the patients whom an investigator prescribes the first Varenicline(Champix) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Conditions: Smoking Cessation
Being tested: 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.

VareniclineDrug
Also called Champix, Chantix
Champix Tablets 0.5mg or Champix Tablets 1mg, depending on the Investigator prescription.
Frequency and duration are according to Package Insert as follows.
"The usual adult dosage for oral use is 0.5 mg of varenicline once daily after eating for days 1 to 3, 0.5 mg twice daily after eating in the morning and evening for days 4 to 7, and 1 mg twice daily after eating in the morning and evening on and after day 8. The drug should be administered to patients for 12 weeks."

Study groups in NCT00772941
Study group	Role	What they receive
Varenicline		Patients taking Varenicline. Receives: Drug: Varenicline

What is being measured

The primary outcome is the main question the study is designed to answer.

Risk Factors for the Frequency of Treatment Related Adverse Events - Gender.
Number of participants with Treatment Related Adverse Events of Varenicline to determine whether gender is a significant risk factor.
Measured: 24 weeks
Risk Factors for the Frequency of Treatment Related Adverse Events - Age.
Number of participants with Treatment Related Adverse Events of Varenicline to determine whether age is a significant risk factor.
Measured: 24 weeks
Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication.
Number of participants with Treatment Related Adverse Events of Varenicline to determine whether Chronic obstructive pulmonary disease as a complication is a significant risk factor.
Measured: 24 weeks
Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Drugs.
Number of participants with Treatment Related Adverse Events of Varenicline to determine whether taking concomitant drugs is a significant risk factor.
Measured: 24 weeks
Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Therapies.
Number of participants with Treatment Related Adverse Events of Varenicline to determine whether receiving concomitant therapies is a significant risk factor.
Measured: 24 weeks
Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline.
Number of participants with Treatment Related Adverse Events to determine whether weight at baseline is a significant risk factor.
Measured: 24 weeks
Risk Factors for the Proportion of Responders - Tobacco Consumption Per Day.
The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.
Measured: 24 weeks
Risk Factors for the Proportion of Responders - Prolonged Administration After 12 Weeks.
The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.
Measured: 24 weeks
Risk Factors for the Proportion of Responders - Antipsychotics as a Concomitant Drug.
The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.
Measured: 24 weeks
Number of Participants With Treatment Related Adverse Events.
Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Varenicline. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.
Measured: 24 weeks
Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.
Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Numbers of Treatment Related Adverse Events were evaluated in company with the causal relationship to Varenicline. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.
Measured: 24 weeks

Secondary outcomes (1)

Number of Participants With Continuous Abstinence Situation by 52 Weeks.
Number of participants with dependence on Varenicline by 52 weeks. Varenicline-dependent Treatment Related Adverse Events are Feeling abnormal, Feeling drunk, Feeling jittery, Disturbance in attention, Dizziness, Memory impairment, Mental impairment, Psychomotor hyperactivity, Sedation, Somnolence, Confusional state, Depersonalisation, Disorientation, Dissociation, Euphoric mood, Mood variable, Mood swings, and Hallucination.
Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009Dec 2012

First posted15 Oct 2008 (estimated)
Study startFeb 2009
Primary completionDec 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 3,939 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00772941
Sponsor's protocol ID: A3051109
Status last verified: Jan 2014
First submitted: 13 Oct 2008
Last updated: 28 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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

All Smoking Cessation trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Drug Use Investigation Of Champix (Regulatory Post Marketing Commitment Plan)
ClinicalTrials.gov ID: NCT00772941
Acronym / sponsor ID: A3051109
Conditions: Smoking Cessation
Study type: Observational
Recruitment status: Completed
Enrolment: 3,939 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 15 Oct 2008 (estimated)
Results: Posted 24 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Varenicline	–	Drug: VareniclinePatients taking Varenicline.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: The patients whom an investigator involving A3051109 prescribes the Varenicline(Champix).

Key inclusion criteria (1 listed)

Patients need to be administered Varenicline(Champix) in order to be enrolled in the surveillance.

Key exclusion criteria (1 listed)

Patients not administered Varenicline(Champix).

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: Champix, ChantixChampix Tablets 0.5mg or Champix Tablets 1mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage for oral use is 0.5 mg of varenicline once daily after eating for days 1 to 3, 0.5 mg twice daily after eating in the morning and evening for days 4 to 7, and 1 mg twice daily after eating in the morning and evening on and after day 8. The drug should be administered to patients for 12 weeks."	Drug	Varenicline

Primary outcome

Risk Factors for the Frequency of Treatment Related Adverse Events - Gender.
Time frame: 24 weeks
Number of participants with Treatment Related Adverse Events of Varenicline to determine whether gender is a significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events - Age.
Time frame: 24 weeks
Number of participants with Treatment Related Adverse Events of Varenicline to determine whether age is a significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication.
Time frame: 24 weeks
Number of participants with Treatment Related Adverse Events of Varenicline to determine whether Chronic obstructive pulmonary disease as a complication is a significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Drugs.
Time frame: 24 weeks
Number of participants with Treatment Related Adverse Events of Varenicline to determine whether taking concomitant drugs is a significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Therapies.
Time frame: 24 weeks
Number of participants with Treatment Related Adverse Events of Varenicline to determine whether receiving concomitant therapies is a significant risk factor.
Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline.
Time frame: 24 weeks
Number of participants with Treatment Related Adverse Events to determine whether weight at baseline is a significant risk factor.
Risk Factors for the Proportion of Responders - Tobacco Consumption Per Day.
Time frame: 24 weeks
The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.
Risk Factors for the Proportion of Responders - Prolonged Administration After 12 Weeks.
Time frame: 24 weeks
The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.
Risk Factors for the Proportion of Responders - Antipsychotics as a Concomitant Drug.
Time frame: 24 weeks
The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.
Number of Participants With Treatment Related Adverse Events.
Time frame: 24 weeks
Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Varenicline. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.
Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.
Time frame: 24 weeks
Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Numbers of Treatment Related Adverse Events were evaluated in company with the causal relationship to Varenicline. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.

1 secondary outcome

Number of Participants With Continuous Abstinence Situation by 52 Weeks.
Time frame: 52 weeks

Results and safety

Results posted to the registry on 24 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Varenicline	3,939	3,257

Primary outcome: Risk Factors for the Frequency of Treatment Related Adverse Events - Gender.

Time frame: 24 weeks. Number. Unit: participants

Measure	Male n = 2179	Female n = 1078
Value	377	336

Male vs Female: p <0.001, Chi-squared

Population analysed: The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.

Primary outcome: Risk Factors for the Frequency of Treatment Related Adverse Events - Age.

Time frame: 24 weeks. Number. Unit: participants

Measure	<65 Years n = 2768	>=65 Years n = 489
Value	571	142

<65 Years vs >=65 Years: p <0.001, Chi-squared

Population analysed: The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.

Primary outcome: Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication.

Time frame: 24 weeks. Number. Unit: participants

Measure	Varenicline - With Chronic Obstructive Pulmonary Disease n = 46	Varenicline - Without Chronic Obstructive Pulmonary Disease n = 3211
Value	23	690

Varenicline - With Chronic Obstructive Pulmonary Disease vs Varenicline - Without Chronic Obstructive Pulmonary Disease: p <0.001, Chi-squared

Population analysed: The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.

Primary outcome: Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Drugs.

Time frame: 24 weeks. Number. Unit: participants

Measure	Varenicline - With Concomitant Drugs n = 738	Varenicline - Without Concomitant Drugs n = 2519
Value	289	424

Varenicline - With Concomitant Drugs vs Varenicline - Without Concomitant Drugs: p <0.001, Chi-squared

Population analysed: The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Varenicline	8 of 3,257 (0.2%)	708 of 3,257 (21.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

Questions about this trial

What is this clinical trial studying?

An observational study of 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 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 28 Feb 2014. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Risk Factors for the Frequency of Treatment Related Adverse Events - Gender. (time frame: 24 weeks). The study lists 11 primary outcomes in all. 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 NCT00772941.

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 28 Feb 2014.