Skip to main content
OpenTrials
Completed

NCT Number: NCT00772941

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Smoking Cessation Behavior Health Behavior

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients not administered Varenicline(Champix).

Treatment and study plan

Varenicline

Drug

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 names: Champix, Chantix

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Secondary outcomes

  1. Number of Participants With Continuous Abstinence Situation by 52 Weeks.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 15, 2008
Registry last updated
Feb 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.