Status:
COMPLETED
Evaluation of the Safety Profile, Quit and Reduction Rate After Nicorette® Gum and Patch Treatment
Lead Sponsor:
McNeil AB
Conditions:
Tobacco Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To evaluate the safety, smoking cessation and reduction rate during 3 months of active nicotine replacement therapy (NRT) and a follow-up period of 3 months in smoking hospital physicians and staff wh...
Detailed Description
Using Nicorette® gum 2 mg, 4 mg and Nicorette® patch 5 mg/16 h, 10 mg/16 h, 15 mg/16 h to alleviate nicotine cravings and withdrawal symptoms and assist smoking cessation in smoking hospital physician...
Eligibility Criteria
Inclusion
- Healthy males and females, aged 18 years or older
- Normal dental status and chewing ability for nicotine gum users; normal skin without excessive hair growth on tested areas for nicotine patch users
- Current daily smoker for at least two years
- Have a carbon monoxide (CO) level of at least 10 parts per million (ppm) after at least 15 smoke-free minutes
- Be motivated to stop smoking with the help of nicotine gum or patch treatment.
- Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the trial
- Be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
Exclusion
- Current use of other tobacco-containing products e.g. snuff, chewing tobacco, cigars, or pipes.
- Use of any other stop-smoking products (nicotine or non-nicotine) or treatment (hypnosis, acupuncture, etc) during the study i.e. during the last 6-month period.
- Unstable angina pectoris or myocardial infarction during the previous 3 months.
- Pregnancy, lactation or intended pregnancy.
- Any major metabolic disease, clinically important renal, hepatic disease.
- Suspected alcohol or drug abuse.
- Participation in other clinical trials in the previous three months, or during study participation.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00749463
Start Date
February 1 2009
End Date
November 1 2009
Last Update
July 13 2012
Active Locations (6)
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1
Beijing ChaoYang Hospital
Beijing, Beijing Municipality, China, 100043
2
People's Hospital affiliated to Beijing University
Beijing, Beijing Municipality, China, 100044
3
No. 1 Hospital affiliated to Zhongshan University
Guangzhou, Guangdong, China, 510080
4
No. 1 Hospital affiliated to Guangzhou Medical University
Guangzhou, Guangdong, China, 510120