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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Smoking

Treatments: Drug: Placebo; Drug: Nicotine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00985985

CHN-Nicotine Mint Lozenge-002

Details and patient eligibility

About

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.

Enrollment: 723 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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723 participants in 4 patient groups, including a placebo group

2mg nicotine lozenge

Experimental group

Description:

2 mg nicotine lozenge

Treatment:

Drug: Nicotine

2 mg placebo

Placebo Comparator group

Description:

2 mg placebo

Treatment:

Drug: Placebo

4 mg nicotine lozenge

Experimental group

Description:

4 mg nicotine lozenge

Treatment:

Drug: Nicotine

4 mg placebo

Placebo Comparator group

Description:

4 mg placebo

Treatment:

Drug: Placebo