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Post Marketing Surveillance Study of Champix in Smoking Cessation for Filipino Patients

NCT ID: NCT00794365

Last Updated: 2010-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

330 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-11-30

Brief Summary

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The primary objective of this Post-Marketing Study is to monitor the safety of a novel smoking cessation drug Varenicline (Champix™) 0.5 mg and 1 mg tablets as used in clinical practice for 12 weeks among Filipino smokers.

The secondary objective is to further evaluate the effectiveness of Varenicline (Champix™) as an aid in smoking cessation based on the 7-day point prevalence of smoking cessation

Detailed Description

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The study will enroll smoking patients.

Conditions

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Smoking Cessation

Keywords

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Smoking; smoking cessation; Philippines; Varenicline

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Open-label

Varenicline

Intervention Type DRUG

There are two packs available for Varenicline (Champix™). The titration pack is prescribed initially to subjects with the recommended 1-week titration phase schedule as follows:

Days 1-3 0.5 mg once daily Days 4-7 0.5 mg twice daily Day 8 - End of treatment 1 mg twice daily

Following the titration period, Varenicline (Champix™) dosing is increased to 1mg twice daily for the remainder of the treatment period. Patient should set the target quit date to coincide with the start of 1 mg twice daily dosing. It should be taken after eating and with a full glass of water.

Interventions

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Varenicline

There are two packs available for Varenicline (Champix™). The titration pack is prescribed initially to subjects with the recommended 1-week titration phase schedule as follows:

Days 1-3 0.5 mg once daily Days 4-7 0.5 mg twice daily Day 8 - End of treatment 1 mg twice daily

Following the titration period, Varenicline (Champix™) dosing is increased to 1mg twice daily for the remainder of the treatment period. Patient should set the target quit date to coincide with the start of 1 mg twice daily dosing. It should be taken after eating and with a full glass of water.

Intervention Type DRUG

Other Intervention Names

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Chantix, Champix

Eligibility Criteria

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Inclusion Criteria

* Smoking adults aged ≥ 18 years intending to quit tobacco use who are prescribed Varenicline (Champix™) by their Physicians and those who are prescribed with Varenicline (Champix™) for the first time.

Exclusion Criteria

* Subjects in whom varenicline (Champix™) may be taken in a manner that is not according to the approved local product document.
* Pregnant or lactating women, or women of childbearing potential not using an acceptable method of contraception
* Subjects with known hypersensitivity to varenicline.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

References

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Park PW, Casiano EM, Escoto L, Claveria AM. Observational study of safety and efficacy of varenicline for smoking cessation among Filipino smokers. Curr Med Res Opin. 2011 Oct;27(10):1869-75. doi: 10.1185/03007995.2011.607436. Epub 2011 Aug 12.

Reference Type DERIVED
PMID: 21838412 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3051079&StudyName=Post%20Marketing%20Surveillance%20Study%20of%20Champix%20in%20Smoking%20Cessation%20for%20Filipino%20Patients

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Other Identifiers

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A3051079

Identifier Type: -

Identifier Source: org_study_id