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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00772941
First received: October 13, 2008
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Smoking Cessation
Drug: Varenicline

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Drug Use Investigation Of Champix (Regulatory Post Marketing Commitment Plan)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Risk Factors for the Frequency of Treatment Related Adverse Events - Gender. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Number of Participants With Continuous Abstinence Situation by 52 Weeks. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 3939
Study Start Date: February 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Varenicline
Patients taking Varenicline.
Drug: Varenicline

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."

Other Name: Champix, Chantix

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients not administered Varenicline(Champix).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772941

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00772941     History of Changes
Other Study ID Numbers: A3051109
Study First Received: October 13, 2008
Results First Received: December 9, 2013
Last Updated: January 28, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014