Status:
COMPLETED
Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.
Lead Sponsor:
Novartis
Conditions:
Smokers
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study is designed to determine the efficacy of high nicotine-specific antibody titers in smoking cessation.
Eligibility Criteria
Inclusion
- Healthy male and female smoking subjects age 18 to 65 years of age
- Subjects must be smoking 10 or more cigarettes per day during the past 12 months
- The exhaled breath carbon monoxide (CO) concentration must be 10 ppm or more at screening. Urine cotinine at screening must be positive.
- The Fagerström Test for Nicotine Dependence (FTND) score of 5 or above at screening.
Exclusion
- Attempted to quit smoking in the three (3) months.
- Prior use of smoking cessation aid.
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00736047
Start Date
August 1 2008
End Date
October 1 2009
Last Update
March 21 2017
Active Locations (2)
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1
Novartis Investigative Site
Mainz, Germany
2
Novartis Investigator Site
Neuss, Germany