Last updated: 11/04/2018 05:56:41
Efficacy and safety study of nicotine mint lozenge (2mg and 4mg) in smoking cessation
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Rate of Successful Smoking Cessation at Week 6
Timeframe: From baseline to Week 6
Secondary outcomes:
Rate of continuous successful smoking cessation at Week 12 and Week 24
Timeframe: From baseline to Week 12 and Week 24
Rate of long-term successful smoking cessation at Week 24
Timeframe: From Week 6 to Week 24
Proportion of participants with seven day point prevalence abstinence
Timeframe: Weekly assessment at Week 1, 2, 4, 6, 12 and Week 24
Mean score of relief of craving/ total withdrawal symptoms
Timeframe: Weekly assessment at Week 1, 2, 3, 4, 5 and Week 6
Mean daily dose at Visit 4, 5, 6, 7 and 10
Timeframe: 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.
Timeframe: 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
Timeframe: Weekly assessments from first treatment dose up to 15 days after last treatment dose
Interventions:
Drug: Nicotine
Drug: Placebo
Enrollment:
723
Observational study model:
Not applicable
Primary completion date:
2011-31-03
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Smoking
Product
nicotine
Collaborators
Not applicable
Study date(s)
May 2009 to August 2011
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Participant must be 18 years of age or older;
- Participant is motivated in smoking cessation using nicotine mint lozenge;
- 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;
Inclusion and exclusion 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.
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2011-31-03
Actual study completion date
2011-31-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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