A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Clinical Study to Evaluate Efficacy and Safety of Nicotine Mint Lozenge (2mg and 4mg) in Smoking Cessation

GlaxoSmithKline0 sites723 target enrollmentMay 2009

ConditionsSmoking

InterventionsNicotine Placebo

DrugsNicotine Placebo

Overview

Phase: Phase 3
Intervention: Nicotine
Conditions: Smoking
Sponsor: GlaxoSmithKline
Enrollment: 723
Primary Endpoint: Rate of Successful Smoking Cessation at Week 6
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

A multi-center, randomized, double-blind, placebo-controlled, 4-arm clinical study to evaluate efficacy and safety of nicotine lozenge (2mg and 4mg) in smoking cessation in adult cigarette smokers who are motivated to quit smoking. Successful quitters or participants who smoke occasionally will be followed up after week 24 till 12 months.

Registry

clinicaltrials.gov

Start Date

May 2009

End Date

March 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participant must be 18 years of age or older;
•Participant is motivated in smoking cessation using nicotine mint lozenge;
•Participant has the habit of smoking regularly every day for at least 1 year;
•Participant is able to read and provide written informed consent.

Exclusion Criteria

•Participant uses other forms of tobacco other than cigarettes such as pipes, cigars, snuff, or smokeless tobacco within 30 days of entry into the study;
•Participant uses other nicotine delivery system such as nicotine gum, nicotine patch, nicotine inhaler, or nicotine nasal spray etc. within 30 days of study entry;
•Participant smoke any other substance within 30 days of study entry (such as cannabis, cocaine, heroin, ice drug, herbal cigarettes etc);
•The participant has a past history of alcohol or drug abuse;
•Participants use other smoking cessation aids (including bupropion, varenicline, traditional Chinese medicines such as herbals, acupuncture, consultation etc), within 30 days of study entry.;
•Participant is currently involved in another clinical trial or has used any investigational medication within 30 days of study entry; Any previous participation in this study;
•Participant is a member of the same household as another clinical subject. Subject is a relative of study site staff or member of the study staff;
•Participant is pregnant or breast-feeding, or has childbearing potential but refusing taking medical contraception measures (within first 24 weeks during study). (Note: All female subjects with childbearing potential must take urine pregnancy test before entry the study, only negative result subject is permitted to this study.);
•Participants who have heart and cerebral vascular disease not stable or controlled by medication or have an irregular heartbeat or have had a heart attack within the last 3 months;
•Participants with poorly controlled high blood pressure by medications, systolic BP greater than or equal to 140mmHg, diastolic BP greater than or equal to 90mmHg after administration;

Arms & Interventions

2mg nicotine lozenge

2 mg nicotine lozenge

Intervention: Nicotine

2 mg placebo

Intervention: Placebo

4 mg nicotine lozenge

Intervention: Nicotine

4 mg placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Rate of Successful Smoking Cessation at Week 6

Time Frame: From baseline to Week 6

Rate of Successful Smoking Cessation at Week 6 was measured by Carbon Monoxide (CO) breath levels.

Secondary Outcomes

Rate of Continuous Successful Smoking Cessation at Week 12 and Week 24(From baseline to Week 12 and Week 24)
Rate of Long-term Successful Smoking Cessation at Week 24(From Week 6 to Week 24)
Proportion of Participants With Seven Day Point Prevalence Abstinence(Weekly assessment at Week 1, 2, 4, 6, 12 and Week 24)
Mean Score of Relief of Craving/ Total Withdrawal Symptoms(Weekly assessment at Week 1, 2, 3, 4, 5 and Week 6)
Mean Daily Dose at Visit 4, 5, 6, 7 and 10(Weeks 1-2, 3-4, 5-6, 7-12 and 13-24)
Mean Change From Baseline in Body Weight at Week 6, Week 12 and Week 24/ Premature Termination.(Baseline, Week 6, 12 and Week 24)
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Cardiovascular AEs and Who Discontinued Due to AEs(Weekly assessments from first treatment dose up to 15 days after last treatment dose)