E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
For the treatment of tobacco dependence by relieving nicotine craving and withdrawal symptoms, thereby facilitating smoking cessation in smokers motivated to quit abruptly. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008374 |
E.1.2 | Term | Cessation of smoking |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053325 |
E.1.2 | Term | Smoking cessation therapy |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059612 |
E.1.2 | Term | Tobacco withdrawal symptoms |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of NMS versus placebo in smokers to achieve continuous abstinence from smoking from the week 2 visit until and including the week 6, week 24, and week 52 visits, respectively. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of NMS versus placebo in smokers to achieve continuous abstinence from smoking from the week 2 visit through all other time points throughout the study (i.e. until and including the week 4, 8, 12, 16, and 20 visits, respectively), To evaluate the efficacy of NMS versus placebo in smokers on 7-day point prevalence abstinence from smoking at week 4 and all remaining visits, To assess the efficacy of NMS versus placebo in smokers on craving and withdrawal symptoms during the initial four weeks on study (daily ratings), as well as point ratings at weeks 4, 6, 8, 12, 16, 20 and 24, To document the compliance of NMS, To assess the level of nicotine substitution by measuring saliva cotinine levels, To document smoking status throughout the study, To evaluate the safety and adverse event profile of NMS, including vital signs, To evaluate the product acceptability of NMS.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. males and females 18 years or older, 2. daily cigarette smoker for the last three years or more, 3. CO level of at least 10 ppm after at least 15 smoke-free minutes, 4. motivated and willing to completely stop smoking from the day after the baseline visit and to stay smokefree. 5. willing to use NMS for at least 12 weeks, 6. female participants of child-bearing potential should have used a medically acceptable means of birth control for at least one month prior to the baseline visit and continue to use birth control during the study period and for one month after the last dose of study drug, 7. evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate, 8. be willing and able to comply with all study procedures and attend the 11 scheduled visits for the 52 weeks duration of the study, 9. be willing and able to use an eDiary according to the provided instructions and willing to return the eDiary at the 12-week visit
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E.4 | Principal exclusion criteria |
1. current use of tobacco-containing products, other than cigarettes (e.g., snuff/snus, chewing tobacco, cigars, or pipe), or smoking of other substances, 2. use of other NRT, bupropion, or varenicline, or undergoing any treatment for tobacco dependence (e.g. acupuncture), during the previous 6 months, 3. unstable angina pectoris or myocardial infarction or stroke during the previous 3 months, 4. pregnancy, lactation or intended pregnancy (non-pregnancy will be verified by urine pregnancy test for female participants of child-bearing potential), 5. suspected alcohol or drug abuse, 6. have a member of the same household who is also a subject in the current study, 7. participation in other clinical trials within the previous 3 months and during study participation, 8. an acute or chronic medical or psychiatric condition or previously diagnosed clinically important renal or hepatic disease, that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 9. subjects with presence of an oral lesion (suspected malignant lesion and/or erosive lesion), requiring further investigation such as biopsy.
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E.5 End points |
E.5.1 | Primary end point(s) |
self-reported continuous abstinence from smoking from the week 2 visit until and including the week 6, week 24 and week 52 visits, respectively, verified by an exhaled carbon monoxide (CO) level of less than 10 ppm at all clinic visits from week 2 until and including weeks 6, 24 and 52, respectively. Missing CO measurements at weeks 8, 16 and/or 20 will not disqualify success if subject claims continuous abstinence from smoking, verified by an exhaled CO level of less than 10 ppm at later visits.
Thus, to be classified as a treatment success:
- after 6 weeks a subject will have to report no smoking between weeks 2 and 6 and to present a CO level of less than 10 ppm at visits weeks 2, 4 and 6, respectively. Subjects who report use of other-than-study NRT, varenicline or bupropion for smoking cessation anytime between weeks 2 and 6 will be classified as treatment failures. - after 24 weeks a subject will have to report no smoking between weeks 2 and 24 and to present a CO level of less than 10 ppm at visits from week 2 to 24, inclusive. Subjects who report use of other-than-study NRT, varenicline or bupropion for smoking cessation anytime between weeks 2 and 24 will be classified as treatment failures. A subject with a missing CO-value at weeks 8, 16 and/or 20 will not be regarded a treatment failure if verified abstinent at later visits, including the 24 weeks visit. - after 52 weeks a subject will have to report no smoking between weeks 2 and 52 and to present a CO level of less than 10 ppm at visits from week 2 to 24, inclusive, as well as at visit week 52. Subjects who report use of use other-than-study NRT, varenicline or bupropion for smoking cessation anytime between weeks 2 and 52 will be classified as treatment failures. A subject with a missing CO-value at weeks 8, 16 and/or 20 will not be regarded a treatment failure if verified abstinent at later visits, including the 52 weeks visit.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of Trial in all participating countries is defined as the last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 19 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 19 |