Evaluation of the Safety Profile, Quit and Reduction Rate After Nicorette® Gum and Patch Treatment

PHASE4CompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

February 28, 2009

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2009

Conditions
Tobacco Dependence
Interventions
DRUG

Nicotine Gum

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

DRUG

Nicotine 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.

Trial Locations (6)

100043

Beijing ChaoYang Hospital, Beijing

100044

People's Hospital affiliated to Beijing University, Beijing

200003

Chang Zheng Hospital, Shanghai

200032

Zhong Shan Hospital affiliated to Fudan University, Shanghai

510080

No. 1 Hospital affiliated to Zhongshan University, Guangzhou

510120

No. 1 Hospital affiliated to Guangzhou Medical University, Guangzhou

Sponsors

Lead Sponsor

All Listed Sponsors
lead

McNeil AB

INDUSTRY