E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | 10057852 |
E.1.2 | Term | Nicotine dependence |
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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 investigate and evaluate subjects’ NMS usage patterns during a three-week period when subjects are given either fixed or flexible directions for use for smoking cessation. Specifically, mean hourly and daily spray consumption as well as maximum usage during specified time intervals will be examined. This will be separately evaluated for subjects who do, and do not, meet the criteria for continuous abstinence, respectively. |
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E.2.2 | Secondary objectives of the trial |
For continuous abstainers:
• to evaluate craving and withdrawal symptoms during three weeks of product use (daily ratings during the first two weeks and one rating on treatment day number 20), • to assess the level of nicotine substitution by measuring saliva cotinine levels at baseline visit and week 3,
For all subjects: • to evaluate self-reported carbon monoxide (CO) -verified continuous abstinence at week 3, • to evaluate the product acceptability of NMS at week 3, and • to evaluate the safety and adverse event profile 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 stop smoking and to be willing to use NMS for the first 3 weeks, 5. female participants of child-bearing potential should have used a medically acceptable means of birth control (see section 7.4 in protocol) 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 medication, 6. 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, 7. be willing and able to comply with all study procedures and attend the two scheduled visits and accept a safety follow up telephone call with questions 30 days after the last study visit, and to use an eDiary according to instructions which will be returned at the 3-weeks visit. |
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E.4 | Principal exclusion criteria |
1. current use of tobacco-containing products, other than cigarette (e.g., snuff/snus, chewing tobacco, cigars, or pipe), 2. use of other NRT, bupropion, or varenicline, or undergoing any treatment for tobacco dependence during the previous 3 months, 3. unstable angina pectoris or myocardial infarction 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. participation in other clinical trials within the previous three months and during study participation, 7. a severe 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• mean hourly and daily number of spray doses used during weeks 1, 2, and 3, as well as throughout the study, • maximum number of spray doses used during any − 30-minute time period; − 1-hour time period; − 24-hour time period; |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |