Evaluation of the Safety Profile, Quit and Reduction Rate After Nicorette® Gum and Patch Treatment
1 other identifier
interventional
300
1 country
6
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 who are motivated to quit
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2009
Shorter than P25 for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2008
CompletedFirst Posted
Study publicly available on registry
September 9, 2008
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
October 1, 2010
CompletedJuly 13, 2012
July 1, 2012
9 months
September 8, 2008
April 23, 2010
July 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Treatment-Related Adverse Events
Percentage of subjects with treatment-related adverse events by preferred term, included if the percentage in any single arm was 1% or higher
24 Weeks
Self-Reported Smoking Reduction
Percentage of subjects self-reporting reduction from baseline in number of cigarettes smoked per day
24 Weeks
Smoking Abstinence
Continuous carbon monoxide (CO)-verified Smoking Abstinence from Quit day
24 Weeks
Secondary Outcomes (4)
Carbon Monoxide (CO)-Verified Smoking Reduction
Baseline to Week 24
Smoking Consumption Per Day
24 Weeks from last visit:
Smoking Consumption Per Week
24 Weeks from last visit:
Point Prevalence Smoking Abstinence (PPSA)
24 Weeks
Study Arms (3)
Gum 2
EXPERIMENTALNicotine Gum 2 mg for subjects smoking less than 20 cigarettes per day; 2 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks
Gum 4
EXPERIMENTALNicotine Gum 4 mg for subjects smoking 20 or more cigarettes per day; 4 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks
Patch
EXPERIMENTALNicotine Patch; Each will use 15 mg/16 h patch for the first 8 weeks, 10 mg/16 h for the following 2 weeks and 5 mg/16 h for the last 2 weeks. Then followed by 12 week off-treatment follow-up.
Interventions
2 mg or 4 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks
Each will use 15 mg/16 h patch for the first 8 weeks, 10 mg/16 h for the following 2 weeks and 5 mg/16 h for the last 2 weeks. Then followed by 12 week off-treatment follow-up.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McNeil ABlead
Study Sites (6)
Beijing ChaoYang Hospital
Beijing, Beijing Municipality, 100043, China
People's Hospital affiliated to Beijing University
Beijing, Beijing Municipality, 100044, China
No. 1 Hospital affiliated to Zhongshan University
Guangzhou, Guangdong, 510080, China
No. 1 Hospital affiliated to Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
Chang Zheng Hospital
Shanghai, Shanghai Municipality, 200003, China
Zhong Shan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joyce Hauze, Sr Specialist, Clinical Research Operations
- Organization
- J&J Consumer and Personal Products Worldwide
Study Officials
- STUDY CHAIR
Jackie Mao
Shanghai Johnson & Johnson Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2008
First Posted
September 9, 2008
Study Start
February 1, 2009
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
July 13, 2012
Results First Posted
October 1, 2010
Record last verified: 2012-07