Drug Use Investigation Of Varenicline (Regulatory Post Marketing Commitment Plan) - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00772941

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	Phase
Smoking Cessation	Drug: Varenicline	Phase IV

MedlinePlus related topics: Quitting Smoking Smoking and Youth

Drug Information available for: Varenicline

U.S. FDA Resources

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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
The incidence of adverse drug reactions in this surveillance. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Continuous abstinence situation by 52 weeks. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	3000
Study Start Date:	November 2008
Estimated Study Completion Date:	October 2012

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."

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."

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

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

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3051109
Study First Received:	October 13, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00772941
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Smoking

ClinicalTrials.gov processed this record on January 14, 2009