Status:
COMPLETED
Efficacy and Safety Study of Nicotine Mint Lozenge (2mg and 4mg) in Smoking Cessation
Lead Sponsor:
GlaxoSmithKline
Conditions:
Smoking
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
723 Patients enrolled
Trial Details
Trial ID
NCT00985985
Start Date
May 1 2009
End Date
March 1 2011
Last Update
June 27 2014
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