E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cessation of oral smokeless tobacco use in current non-smokers. |
|
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 | 10053325 |
E.1.2 | Term | Smoking cessation therapy |
|
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 compare the efficacy of varenicline to placebo for cessation of use of smokeless tobacco assessed using the 4 week Continuous Quit Rate (CQR) at the end of treatment. |
|
E.2.2 | Secondary objectives of the trial |
To compare varenicline with placebo for the Continuous Abstinence (CA) of smokeless tobacco from Weeks 9 through to 26. • Compare varenicline with placebo for the 7 day Point Prevalence (PP) of abstinence at the end of treatment (Week 12). • Compare varenicline with placebo for the 7 day Point Prevalence (PP) of abstinence at the end of study (Week 26). • Compare varenicline with placebo for the long term quit rate (LTQR) of smokeless tobacco from Weeks 9 through to 26. • To assess the safety and tolerability of varenicline with placebo, for 12 weeks of treatment in users of smokeless tobacco. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Have evidence of a personally signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of and has understood all pertinent aspects of the study. 2. Male or female daily smokeless tobacco users aged 18 years and older, who are motivated to stop use of all tobacco products. 3. Subjects must be daily users of nicotine containing smokeless tobacco and using smokeless tobacco on at least 8 occasions per day averaged over a week. 4. Have used smokeless tobacco for at least 1 year prior to screening with no period of abstinence >3 months in the past year. 5. If female, be not of childbearing potential (ie, surgically sterile or postmenopausal for at least one year), or be non-pregnant and using an acceptable method of birth control (such as implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomised partner) for a least one month prior to the screening visit, and for the duration of the study period. 6. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. |
|
E.4 | Principal exclusion criteria |
Subjects with any of the following will not be included in the study: 1. Subjects using nicotine containing products (including smoking tobacco) other than smokeless tobacco for 3 months prior to screening. 2. Subjects with exhaled Carbon Monoxide (CO) ≥10 ppm at baseline. 3. Subjects who have used varenicline, bupropion, or NRT within 3 months of screening. 4. Subjects currently or within the past 12 months requiring treatment for depression or have a current or prior history of panic disorder, psychosis, bipolar disorder or any other serious mental illness. 5. Subjects with a history of drug (except nicotine) or alcohol abuse or dependence within the past 12 months. 6. Subjects receiving concomitant treatment with another investigational drug within 30 days of the study baseline visit or with plans to take another investigational drug within 30 days of study completion (after Week 26 visit). 7. Subjects with an uncontrolled, unstable clinically significant medical condition (eg, renal, hepatic, endocrine, respiratory, cardiovascular, haematologic, immunologic, cerebrovascular disease, diabetic or have malignancy), which, in the opinion of the investigator, may interfere with the interpretation of safety or efficacy evaluations. 8. The contraindication of varenicline is hypersensitivity to the active substance or to any of the excipients. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The 4-week Continuous Quit Rate (CQR) from smokeless tobacco use assessed for the 4 weeks prior to the end of treatment (Week 9 through to 12). This will be assessed using the nicotine use inventory (NUI) and confirmed by salivary cotinine at the weekly visits from Week 9 through to 12. |
|
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 | Information not present in EudraCT |
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 | 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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 17 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 18 |
E.8.9.2 | In all countries concerned by the trial days | 0 |