Varenicline (Champix®) Special Investigation (Regulatory Post Marketing Commitment Plan)

Smoking Cessation Clinical Trial

Official title:

Champix Tablets Special Investigation -Retrospective Survey For Subjects Who Have Been Retreated With Champix.-(Regulatory Post Marketing Commitment Plan).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061710
• Other study ID #: A3051117
• Status: Completed
• Phase: Phase 4
• First received: February 1, 2010
• Last updated: January 27, 2015
• Start date: July 2010
• Est. completion date: February 2014

Study information

• Verified date: January 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to collect the efficacy and safety information in subjects who have been retreated with varenicline (Champix®) within 52 weeks of initial treatment for their appropriate use in daily practice and are participants for varenicline Drug Use Investigation protocol A3051109 ((NCT# NCT00772941).

Description:

The subjects have been retreated with varenicline within 52 weeks, and subjects have been enrolled to varenicline Drug Use Investigation protocol A3051109.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Male or Female subjects intend to quit tobacco use who are prescribed varenicline (Champix®) by their Physicians

• Subjects who are prescribed varenicline (Champix®) for the second time within 52 weeks of initial treatment.

Exclusion Criteria:

Non-participants of varenicline (Champix®) Drug use Investigation protocol A3051109.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• varenicline
Dosage form: tablet 0.5mg, tablet 1mg. The usual adult dosage for oral use is 0.5 mg once daily after eating on Days 1 to 3; 0.5 mg twice daily after eating in the morning and evening on Days 4 to 7, and 1 mg twice daily after eating in the morning and evening on Day 8 and thereafter. The drug should be administered to subjects 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	Number of Participants With Treatment-Related Adverse Events (AEs)	An AE was any untoward medical occurrence attributed to veranicline in a participant who received veranicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline.	24 weeks	Yes
Primary	Number of Responders to Varenicline Treatment	Number of participants who succeeded in smoking cessation from 12 weeks through 24 weeks of the observation period.	24 weeks	No
Secondary	Number of Treatment-Related Adverse Events (AEs) Unlisted in Japanese Package Insert	An AE was any untoward medical occurrence attributed to varenicline in a participant who received varenicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline.	24 weeks	Yes
Secondary	Number of Participants With Risk Factors Likely to Affect the Frequency of Treatment-Related Adverse Events (AEs)		24 weeks	Yes
Secondary	Number of Participants With Risk Factors Likely to Affect the Proportion of Responders		24 weeks	No

External Links

•   To obtain contact information for a study center near you, click here.