E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cigarette smokers willing to quit |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057852 |
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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 demonstrate the efficacy of dianicline 40 mg bid versus placebo as an aid to smoking cessation in cigarette smokers after seven weeks of treatment. |
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E.2.2 | Secondary objectives of the trial |
- To demonstrate the efficacy of dianicline on reduction craving for nicotine - To evaluate the clinical and biological safety and tolerability of dianicline during a 7-week treatment period - To evaluate the abstinence rate during a 19-week follow-up post treatment period |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Outpatients - Over legal age smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit |
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E.4 | Principal exclusion criteria |
Related to study methodology 1. Refusal or inability to give informed consent to participate in the study. 2. Level of motivation to quit less than 6 on the ten-point Likert Scale. 3. Not able to follow verbal and written instructions and to complete all aspects of the study. 4. Other participant in a household enrolled in the study. 5. Patients who have taken an investigational drug within the past six months prior to the screening visit. 6. Patients who had a previous quit attempt (≥1 day, with or without any assistance) in the previous three months (before screening). 7. Patients who have smoked or consumed non-tobacco cigarettes or any form of tobacco product (other than cigarettes such as cigars, pipes, smokeless tobacco, etc) more than 3 times within the 3 months preceding the screening visit. 8. Patients who currently present with (based on DSM-IV): − Psychotic Disorder, − Major Depressive Episode.
Related to dianicline 9. Pregnant or breast-feeding women. 10. Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy. Medically acceptable methods of birth control for this study include approved hormonal contraceptive medications or devices, approved intra-uterine contraceptive devices, use of two combined barrier methods. 11. Patients who have suffered from a myocardial infarction, unstable angina or other major cardiovascular event within the past week prior to screening. 12. Patients who have a history of multiple allergic reactions to medications in two drug classes. 13. Patients who have QTcF ≥ 500 ms on the ECG. 14. Patients with severe renal impairment defined as: − Creatinine clearance < 30 mL/mm 15. Patients who have an abnormal laboratory test of potential clinical significance at screening: − AST or ALT levels > 2 X ULN (Upper Limit of Normal range for the laboratory). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Four-week continuous abstinence from smoking (W4 to W7) reported by the patient, confirmed by CO and plasma cotinine measurements
- Smoking status Through direct inquiry of the patient, using daily recording from the patient, the investigator will determine whether the patient has been continuously abstinent (or non-abstinent) from tobacco cigarette smoking since the previous scheduled visit.
- Carbon Monoxide Exhaled carbon monoxide (CO) testing will be performed as a biomedical marker of smoking status. To be considered abstinent, the patient must have a level of exhaled CO ≤ 10 ppm. Technical procedures for collection of exhaled CO will be escribed in a separate manual to be provided to the investigational sites.
and (when measured) - Cotinine measurements (only assessed at D28/W4 and D49/W7) To confirm smoking status and exhaled CO results, plasma cotinine measurements will be performed. In order to be considered to be abstinent from nicotine, a patient must have plasma cotinine levels of less than or equal to 8 micrograms/L. A validated LCMS/MS method with a limit of quantification of 4 ng/ml for cotinine will be used. |
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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 | No |
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 | 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 | 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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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 | |
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 | 7 |