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NCT00808015 Clinical Trial

ASIA CHOICES CHampix (Varenicline) Observational Investigation in the CEssation of Smoking

Smoking Cessation Clinical Trial

— ASIA CHOICES  

Official title:
ASIA CHOICES CHampix Observational Investigation in the CEssation of Smoking

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00808015
Other study ID # A3051112
Secondary ID
Status Completed
Phase N/A
First received December 12, 2008
Last updated April 21, 2015
Start date February 2009
Est. completion date July 2010

Study information
Verified date April 2015
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority India: Central Drugs Standard Control Organization
Study type Observational

Clinical Trial Summary

The purpose of this study is to describe the characteristics of the smoker who wants to quit and his/her treating physician, in addition to determine the safety and effectiveness of Champix in the real-world setting of smokers in routine clinical practice.

Description:

Sampling Method Description: Patients enrolled after being prescribed Champix for smoking cessation at the sole discretion of treating physician and patient.

Recruitment information / eligibility
Status Completed
Enrollment 1373
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients enrolled should meet the usual prescribing criteria for Champix® as per the local product information and should be entered into the trial at the investigator's discretion

Exclusion Criteria:

- All patients enrolled should meet the usual prescribing criteria for Champix® as per the local product information and should be entered into the trial at the investigator's discretion

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• varenicline
Champix will be prescribed as per usual practice and at the sole discretion of the physician

Locations
Country Name City State
China Pfizer Investigational Site Beijing Beijing
China Pfizer Investigational Site Beijing Beijing
China Pfizer Investigational Site Beijing Beijing
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Changsha Hunan
China Pfizer Investigational Site Chengdu Sichuan
China Pfizer Investigational Site Guangzhou Guangdong
China Pfizer Investigational Site Guangzhou Guangdong
China Pfizer Investigational Site Guangzhou Guangdong
China Pfizer Investigational Site Nanjing Jiangsu
China Pfizer Investigational Site Nanning
China Pfizer Investigational Site Shanghai
China Pfizer Investigational Site Shanghai
China Pfizer Investigational Site Shanghai
China Pfizer Investigational Site Shanghai
China Pfizer Investigational Site Shanghai
China Pfizer Investigational Site Shanghai
China Pfizer Investigational Site Shanghai
China Pfizer Investigational Site Shanghai
China Pfizer Investigational Site Shanghai
China Pfizer Investigational Site Shanghai
China Pfizer Investigational Site Shenyang Liaoning
China Pfizer Investigational Site Shenyang Liaoning
China Pfizer Investigational Site Shenyang Liaoning
China Pfizer Investigational Site Shenyang Liaoning
China Pfizer Investigational Site Shenzhen Guangdong
China Pfizer Investigational Site Shijiazhuang
China Pfizer Investigational Site Suzhou Jiangsu
China Pfizer Investigational Site Taiyuan Shanxi
China Pfizer Investigational Site Tianjin Tianjin
China Pfizer Investigational Site Tianjin
China Pfizer Investigational Site Tianjin
China Pfizer Investigational Site Tianjin
China Pfizer Investigational Site Wuhan
China Pfizer Investigational Site Wuhan Hubei
China Pfizer Investigational Site Xi'an Shaanxi
China Pfizer Investigational Site Xi'an Shaanxi
China Pfizer Investigational Site Xi'an Shaanxi
China Pfizer Investigational Site Xian Shaanxi
India Pfizer Investigational Site Ahmadabad Gujarat
India Pfizer Investigational Site Chennai
India Pfizer Investigational Site Cochin Kerala
India Pfizer Investigational Site Coimbatore Tamil Nadu
India Pfizer Investigational Site Daryaganj New Delhi
India Pfizer Investigational Site Delhi New Delhi
India Pfizer Investigational Site Delhi New Delhi
India Pfizer Investigational Site Delhi
India Pfizer Investigational Site Delhi, New Delhi
India Pfizer Investigational Site Hyderabad Andhra Pradesh
India Pfizer Investigational Site Mumbai Maharashtra
India Pfizer Investigational Site Mumbai Maharashtra
India Pfizer Investigational Site Mumbai Maharashtra
India Pfizer Investigational Site Mumbai Maharashtra
India Pfizer Investigational Site New Delhi
India Pfizer Investigational Site New Delhi Delhi
India Pfizer Investigational Site Tthiruvananthapuram Kerala
Korea, Republic of Pfizer Investigational Site Cheonan-si Chungcheongnam-do
Korea, Republic of Pfizer Investigational Site Daegu
Korea, Republic of Pfizer Investigational Site Daegu
Korea, Republic of Pfizer Investigational Site Daegu-si
Korea, Republic of Pfizer Investigational Site Daejeon
Korea, Republic of Pfizer Investigational Site Daejeon
Korea, Republic of Pfizer Investigational Site Goyang-si Gyeonggi-do
Korea, Republic of Pfizer Investigational Site Iksan-Si Jeollabuk-Do
Korea, Republic of Pfizer Investigational Site Incheon
Korea, Republic of Pfizer Investigational Site Incheon-Si
Korea, Republic of Pfizer Investigational Site Seongnam-si Gyeonggi-do
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Suwon
Korea, Republic of Pfizer Investigational Site Suwon-si Gyeonggi-do
Korea, Republic of Pfizer Investigational Site Yangsan-si Gyeongnam
Philippines Pfizer Investigational Site Angeles City Pampanga
Philippines Pfizer Investigational Site Batac Ilocos Norte
Philippines Pfizer Investigational Site Davao City
Philippines Pfizer Investigational Site Marikina City
Philippines Pfizer Investigational Site Pasay City
Philippines Pfizer Investigational Site Quezon City
Philippines Pfizer Investigational Site Quezon City
Philippines Pfizer Investigational Site Quezon City
Philippines Pfizer Investigational Site San Fernando City La Union
Philippines Pfizer Investigational Site San Juan Batangas
Philippines Pfizer Investigational Site Tarlac City Tarlac
Philippines Pfizer Investigational Site Urdaneta City Pangasinan

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

China,  India,  Korea, Republic of,  Philippines, 

Outcome
Type Measure Description Time frame Safety issue
Other Varenicline Prescription Status Prescribed status was assessed using the following question in consent record form: Would a maintenance period of the drug be prescribed to the participant after this study ends (Yes/No). Missing values were recorded as 'unknown'. After last observed study visit (Week 12 or ET) No
Other Average Daily Dose of Varenicline Days 1-3, Days 4-7, Day 8 through last observed study visit (Week 12 or ET) No
Other Median Duration of Treatment of Varenicline The duration was defined as the total number of dosing days from first to last day of each study treatment. Baseline through last observed study visit (Week 12 or ET) No
Other Concomitant Drug Treatments Baseline through Last observed study visit (Week 12 or ET) No
Primary Percentage of Participants With Smoking Abstinence at Week 12 Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4. Week 12 No
Secondary Percentage of Participants With Smoking Abstinence Before Last Observed Study Visit Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4. Last observed study visit (Week 12 or early termination [ET]) No
Secondary Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11 Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4. Week 3 through Week 11 No
Secondary CO Level at Last Observed Study Visit The CO level was measured from exhaled air of the participant using CO analyzer at the last observed study visit which was the last available CO level recorded after baseline. The CO level was only measured if it was a part of the usual practice at the site. Last observed study visit (Week 12 or ET) No
Secondary Average Weekly Number of Cigarettes Smoked at Last Observed Study Visit The average number of cigarettes smoked per day over the last 7 days was collected as a part of nicotine use inventory assessment through consent record form module which included a questionnaire: Did the participant smoke any cigarettes (even a puff) in last 7 days (Yes/No) and Did the participant use any other tobacco products (example- pipe, cigars, chew, snuff) in last 7 days (Yes/No). Last observed study visit (Week 12 or ET) No
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