E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 |
The primary objectives of this study are: •to compare ONS (two sprays of 1 mg nicotine) and NiQuitin lozenge 2 mg after 5 hours of witnessed abstinence with respect to urges to smoke during the first 5 minutes after start of treatment., and •to compare ONS (two sprays of 1 mg nicotine) and NiQuitin lozenge 4 mg after 5 hours of witnessed abstinence with respect to urges to smoke during the first 5 minutes after start of treatment.
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are: •to compare the study treatments with respect to the time to a 25%, 50%, 75%, and 90% reduction of the baseline urges to smoke score, •to compare the proportion of subjects reaching 25%, 50%, 75%, and 90% reduction of the baseline urges to smoke within 1, 3, 5, and 10 minutes for the study treatments, •to describe the urges to smoke profile of the study treatments during 2 hours after dose, •to evaluate acceptability of the study treatments, •to evaluate tolerability and safety of the study treatments.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Healthy male or female subjects between the ages of 19 and 55 years, inclusive. Health is defined as the absence of clinically relevant abnormalities as identified by a detailed medical history, a physical examination, and blood pressure, pulse rate and hemoglobin measurements, as judged by the investigator or an authorized physician. The responsible physician may order additional investigations or analyses if necessary. 2.Smoking within 30 minutes of waking up. 3.Smoking of at least 10 cigarettes daily during at least one year preceding inclusion. 4.For females: Postmenopausal state (absence of menstrual discharge for at least two years and a serum FSH level exceeding 30 IU/L) or premenopausal/perimenopausal state with an effective means of contraception (oral, injected or implanted hormonal contraceptives, intrauterine device, or status after operative sterilization), or declared absence of sexual contact during the study. 5.Body Mass Index (BMI) between 17.5 and 32.0 kg/m2 and a total body weight >= 50.0 kg. 6. A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study. 7.Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified in the protocol.
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E.4 | Principal exclusion criteria |
1.Evidence or history of an acute or chronic medical or psychiatric condition or allergy or laboratory abnormality, or of use of drugs that, in the judgment of the investigator or an authorized study physician, increases the risk associated with study participation or interfere with the interpretability of study results. 2.Females: Pregnancy, breast-feeding, premenopausal, or perimenopausal, state with insufficient contraception as specified under Inclusion Criteria. 3.History of regular alcohol consumption in the 6 months before screening, exceeding weekly limits of 2 L of wine or 5 L of beer or 0.6 L of spirits for females, and 3 L of wine or 7.5 L of beer or 0.9 L of spirits for males. The investigator may lower these limits if a subject consumes different types of alcoholic beverages. 4.Use of other NRT, bupropion, or varenicline, or history of a quit attempt later than 3 months before the screening visit. 5.Treatment with an investigational product, other than those described in this protocol, between 1 month preceding the first treatment visit and the last treatment visit of the study. 6.Pathological oral status interfering with normal muscular, sensory, or absorptive function of the oral cavity. 7.Prior regular use of nicotine mouthspray and/or nicotine lozenge. 8.Relationship to persons involved directly with the conduct of the study (i.e,, principal investigator; subinvestigators; study coordinators; other study personnel; employees or contractors of the sponsor or Johnson & Johnson subsidiaries; and the family of each).
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary study endpoints are the area under the urges to smoke-vs.-time curve (AUC) from start of administration until 5 minutes thereafter, AUC5min, the AUC from the start of administration until 3 minutes thereafter, AUC3min, and the AUC from the start of administration until 1 minute thereafter, AUC1min. |
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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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | 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 | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Strenght of NiQuitin will be unknown to subjects and personell otherwise open |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.5 | 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 | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |