E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Smoking cessation therapy |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10053325 |
E.1.2 | Term | Smoking cessation therapy |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 assess the effects of Nicachet 4 mg nicotine powder in pouch on the oral mucosa over a 42-day smoke-free period. |
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E.2.2 | Secondary objectives of the trial |
To assess the efficacy of Nicachet 4 mg nicotine powder in pouch on abstinence from smoking during a 42-day smoke-free period.
To assess the degree of saliva cotinine substitution with Nicachet 4 mg nicotine powder in pouch during smoking abstinence.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy adult male and female smokers, 18-50 years, will be recruited using an advertisement in the local newspaper. Following a telephone interview to evaluate eligibility, potential participants are invited to a screening visit. The potential participants will then submit a Health Declaration that will be checked by the responsible Investigator. In order to be enrolled in the study subjects have to • be aged 18-50 years • be smoking >7 cigarettes per day • having smoked for >2 years • be motivated to stop smoking and to comply with the protocol • be able to understand written and spoken Swedish language • sign a written informed consent • show a score of >3 on the Fagerström Tolerance Questionnaire on Nicotine Dependence (FTQ) • not participate in any other clinical trial
The FTQ measures nicotine dependence in tobacco smokers on a scale of 0 to 11. |
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E.4 | Principal exclusion criteria |
Any subjects showing the following criteria will be excluded: • symptoms from the oral mucosa, • cardiovascular disease (myocardial infarction within the preceding 3 months), • pregnancy • breast feeding • on psychotropic medication • abuse of alcohol or illegal drugs within the last 6 months • use of snuff or NRT products. • participation in other clinical trial.
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E.5 End points |
E.5.1 | Primary end point(s) |
Oral Saftey and Tolerability. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 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 | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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 | |
E.8.9.1 | In the Member State concerned days | 45 |
E.8.9.2 | In all countries concerned by the trial days | 45 |