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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01061710
First received: February 1, 2010
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention Phase
Smoking Cessation
Drug: varenicline
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Champix® Tablets Special Investigation - Retrospective Survey For Subjects Who Have Been Retreated With Champix (Regulatory Post Marketing Commitment Plan)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The frequency of treatment related adverse events. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • The proportion of responders to varenicline treatment. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment-related unlisted adverse events in Japanese Package Insert. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Risk factors likely to affect the frequency of treatment related adverse events. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Risk factors likely to affect the proportion of responders. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
varenicline (Champix®)
Subjects who have been retreated with varenicline within 52 weeks and have been enrolled to varenicline protocol A3051109.
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.
Other Name: Chantix, Champix

Detailed Description:

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

  Eligibility

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

The subjects who have been retreated with varenicline in A3051109 (NCT# NCT00772941) within 52 weeks of initial treatment.

Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061710

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: NCT01061710     History of Changes
Other Study ID Numbers: A3051117
Study First Received: February 1, 2010
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Smoking
smoking cessation
Japanese
varenicline
retreatment
Regulatory Post Marketing Commitment Plan

Additional relevant MeSH terms:
Smoking
Habits
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 April 16, 2014