NCT00985985已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 723
- 主要终点
- Rate of Successful Smoking Cessation at Week 6
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
2mg nicotine lozenge
Experimental
2 mg nicotine lozenge
干预措施: Nicotine (Drug)
2 mg placebo
Placebo Comparator
2 mg placebo
干预措施: Placebo (Drug)
4 mg nicotine lozenge
Experimental
4 mg nicotine lozenge
干预措施: Nicotine (Drug)
4 mg placebo
Placebo Comparator
4 mg placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of Successful Smoking Cessation at Week 6
时间窗: From baseline to Week 6
Rate of Successful Smoking Cessation at Week 6 was measured by Carbon Monoxide (CO) breath levels.
次要结局
- 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)
研究者
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