E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Smoking during pregnancy
Specifically smoking 5 or more cigarettes currently (i.e. whilst pregnant) and having smoked 10 or more cigarettes prior to pregnancy. |
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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 SNAP trial will investigate whether or not NRT is more effective and cost effective than placebo in achieving smoking cessation for women who and are between 12 and 24 weeks pregnant, who currently smoke 5 or more cigarettes daily and who smoked 10 or more cigarettes daily before pregnancy. |
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E.2.2 | Secondary objectives of the trial |
To compare at 2 years after delivery: the effects of maternal nicotine replacement therapy patch and placebo patch use in pregnancy on behaviour and cognitive development in children. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Eligible women are women between 12 and 24 weeks pregnant, who report smoking at least ten cigarettes daily before pregnancy and who still currently smoke at least five cigarettes daily. They also must have an exhaled carbon monoxide reading above 8 ppm [i.e. which demonstrates that they are a smoker]. |
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E.4 | Principal exclusion criteria |
Women with the following contraindications to the use of NRT will be excluded:
severe cardiovascular disease, unstable angina, cardiac arrhythmias, recent cerebrovascular accident or TIA, chronic generalized skin disorders or known sensitivity to nicotine patches, chemical dependence / alcohol addiction problems.
Also, women who cannot give informed consent and those with known major fetal anomalies will be excluded.
Intra-uterine growth restriction (IUGR) is not an exclusion criterion. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Self-reported, prolonged and total abstinence from smoking or the use of any non-pharmacological nicotine containing substances between a quit date set within two weeks of randomisation and immediately prior to childbirth. |
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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 | 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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | 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 | 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
|
The trial will end when the last questionnaire is returned from the final child to be born to a women enrolled in the study.
Children born to women who are enrolled into the trial will be followed up by postal questionnaire on their 2nd birthday, so the trial will end when the parent(s) of the child born within the study return this. This will be approximately 2 years after the last woman in the trial gave birth. |
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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 | 6 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 0 |