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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772941
• Other study ID #: A3051109
• Status: Completed
• Phase: N/A
• First received: October 13, 2008
• Last updated: January 28, 2014
• Start date: February 2009
• Est. completion date: December 2012

Study information

• Verified date: January 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3939
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients not administered Varenicline(Champix).

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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."

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 weeks	Yes
Primary	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.	24 weeks	Yes
Primary	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.	24 weeks	Yes
Primary	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.	24 weeks	Yes
Primary	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.	24 weeks	Yes
Primary	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.	24 weeks	Yes
Primary	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.	24 weeks	Yes
Primary	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.	24 weeks	Yes
Primary	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.	24 weeks	Yes
Primary	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.	24 weeks	Yes
Primary	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.	24 weeks	Yes
Secondary	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.	52 weeks	No

External Links

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