E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
problems related to the use of nicotine |
Disturbi correlati all'assunzione di nicotina |
|
E.1.1.1 | Medical condition in easily understood language |
Nicotine addiction |
Dipendenza da nicotina |
|
E.1.1.2 | Therapeutic area | Health Care [N] - Population Characteristics [N01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068678 |
E.1.2 | Term | Nicotine abuse |
E.1.2 | System Organ Class | 100000004873 |
|
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 |
This study intends to evaluate the efficacy and safety of varenicline 1 mg BID in the cessation of smoking electronic cigarette (single users) or combined use, electronic and classical cigarette (dual users). |
Questo studio intende valutare efficacia e tollerabilità della vareniclina 1 mg BID nella disassuefazione dal fumo di sigaretta elettronica (single users) o uso combinato, sigaretta elettronica e sigaretta classica (dual users). |
|
E.2.2 | Secondary objectives of the trial |
Safety, predictors of abstinence at the end of the study, the percentage of study participants retention. |
Sicurezza, predittori di astinenza alla fine dello studio, percentuale di ritenzione dei partecipanti allo studio. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The study will enroll 140 Smokers of Electronic Cigarette (single users), from at least three months, who use liquid with nicotine and 140 smokers who combined use of electronic cigarette with nicotine and cigarette classic (dual users), from at least 3 months. Smokers willing to stop smoking, will be invited to participate in the study. |
Lo studio arruolerà 140 fumatori di sigaretta elettronica (single users) da almeno 3 mesi e che utilizzino liquido con nicotina e 140 fumatori che fanno uso combinato da almeno 3 mesi di sigaretta elettronica con nicotina e sigaretta classica (dual users). I fumatori disposti a smettere, saranno invitati a partecipare allo studio. |
|
E.4 | Principal exclusion criteria |
It will be excluded patients with psychiatric illnesses and women who are pregnant and breastfeeding women. Patients with severe renal impairment and symptomatic vascular disease (including a history of ischemic heart disease, stroke) are also excluded from the study. |
Saranno esclusi i pazienti affetti da malattie psichiatriche e le donne in stato di gravidanza e le donne in allattamento. I pazienti con grave compromissione della funzionalità renale e malattia vascolare sintomatica (tra cui una storia di cardiopatia ischemica, ictus) saranno anche esclusi dallo studio. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
% of success in the Varenicline vs Placebo Group |
% di successo nel gruppo Vareniclina vs Placebo |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
at week 24th |
Alla settimana 24 |
|
E.5.2 | Secondary end point(s) |
Safety, predictors of abstinence at the end of the study, % of intention of the study participants |
Sicurezza, predittori di astinenza a fine studio, % di intenzione dei partecipanti allo studio |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Safety at each clinic visit Predictors of abstinence at the end of the study and % of intention of the study participants at week 24th |
Sicurezza ad ogni visita Predittori di astinenza a fine studio e % di intenzione dei partecipanti allo studio alla settimana 24 |
|
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 | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 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
|
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |