Status:
COMPLETED
Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy
Lead Sponsor:
McNeil AB
Conditions:
Smoking Cessation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A comparison of a novel nicotine replacement therapy and placebo treatment in smokers motivated to quit smoking.
Detailed Description
Efficacy and safety study following use of a novel nicotine replacement therapy.
Eligibility Criteria
Inclusion
- 18 years or older male and female cigarette smokers motivated and willing to stop smoking
- Female participants of child-bearing potential should use a medically acceptable means of birth control.
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate.
Exclusion
- Unstable angina pectoris or myocardial infarction during the previous 3 months.
- Pregnancy, lactation or intended pregnancy (non-pregnancy will be verified by urine pregnancy test for female participants of child-bearing potential).
- Participation in other clinical trials within the previous three months and during study participation.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
479 Patients enrolled
Trial Details
Trial ID
NCT00882375
Start Date
March 1 2009
End Date
June 1 2010
Last Update
July 2 2012
Active Locations (3)
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1
Gentofte University Hospital
Hellerup, Denmark, 2900
2
University of Heidelberg
Mannheim, Germany, 68159
3
University Hospital of Tuebingen
Tübingen, Germany, 72076