Efficacy and Safety Study of Nicotine Mint Lozenge (2mg and 4mg) in Smoking Cessation - Full Text View

Purpose

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.

Condition	Intervention	Phase
Smoking	Drug: Nicotine Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Rate of Successful Smoking Cessation at Week 6 [ Time Frame: Baseline to Week 6 of treatment administration ] [ Designated as safety issue: No ]
The primary efficacy variable was 28-days continuous abstinence at 6 weeks (confirmed by Carbon Monoxide (CO)). Successful abstinence was confirmed if the 6-week CO measurement, as well as all CO easurements during the preceding 28 days, were all 10 parts per million (ppm) or less.

Secondary Outcome Measures:

Rate of continuous successful smoking cessation at Week 12, Week 24 and 12 Months [ Time Frame: Week 12, Week 24 and 12 months ] [ Designated as safety issue: No ]
Continuous abstinence at the end of Weeks 12 and 24, verified by measurement of CO breath levels (proportion of participants who achieved the primary end-point as well as total abstinence from all tobacco products through week 12 or 24, as verified by CO <= 10 Parts ppm at the 12 or 24-week visit)
Rate of long-term successful smoking cessation at Week 24 [ Time Frame: Week 6- Week 24 ] [ Designated as safety issue: No ]
Rate of long-term successful smoking cessation at Week 24 was defined as the proportion of participants who achieved the primary end-point with no more than size cumulative days of smoking from Week 6 to Week 24.
Proportion of participants with seven day point prevalence abstinence [ Time Frame: Weekly assessment at Week 1,2,4,6,12 and Week 24 ] [ Designated as safety issue: No ]
Seven day point prevalence abstinence was defined as complete abstinence from smoking for the 7 days up to and including the evaluation day.
Mean score of relief of craving/total withdrawal symptoms [ Time Frame: Weekly assessment at Week 1, 2, 3, 4, 5 and Week 6 ] [ Designated as safety issue: No ]
The evaluation of withdrawal and craving symptoms was carried out every day with the Minnesota Nicotine Withdrawal Scale. Participants graded a series of 9 questions on a 5 grade scale; none, slight, moderate, and 5: severe.
Mean change from baseline in body weight at Week 6, Week 12 and Week 24/ Premature Termination [ Time Frame: Week 6, 12 and Week 24 ] [ Designated as safety issue: No ]
Change in body weight was analyzed at Weeks 6, 12, and 24
Adverse events [ Time Frame: Weekly assessments ] [ Designated as safety issue: No ]

Enrollment:	723
Study Start Date:	May 2009
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 2mg nicotine lozenge 2 mg nicotine lozenge	Drug: Nicotine 2 mg or 4 mg nicotine lozenge
Placebo Comparator: 2 mg placebo 2 mg placebo	Drug: Placebo placebo lozenge
Experimental: 4 mg nicotine lozenge 4 mg nicotine lozenge	Drug: Nicotine 2 mg or 4 mg nicotine lozenge
Placebo Comparator: 4 mg placebo 4 mg placebo	Drug: Placebo placebo lozenge

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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;
Participants having hyperthyroidism or current application of insulin for diabetes;
Participants having myocardial infarction or cerebral vascular accidents recently (within the past 3 months);
Participants who are unable to fulfill study requirements in relation to conforming to the visit schedule;
Participants who are allergy to Aspartame or Phenylpyruvic acid (an edulcorant is widely used in foods and drinks)，or have diagnosed with Phenylketonuria;
The other clinically significant pulmonary, gastrointestinal, liver, neurological, renal or haematological abnormalities.( unstable or worsening angina pectoris, Prinzmetal's angina, nerve or circulatory problems, rheumatoid arthritis, moderate and severe COPD);
A medical history that, in the opinion of the investigator, might jeopardize the safety of the subject or the validity for the study results.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985985

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00985985 History of Changes
Other Study ID Numbers:	CHN-Nicotine Mint Lozenge-002
Study First Received:	September 2, 2009
Last Updated:	January 24, 2013
Health Authority:	China: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

smoking cessation
nicotine lozenge
nicotine replacement therapy

Additional relevant MeSH terms:

Smoking
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013