E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers will be used in the study however the gel device being investigated has been developed with the aim of aiding swallowing in stroke and other dysphagic patients. |
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E.1.1.1 | Medical condition in easily understood language |
Swallowing difficulties in stroke and other patients. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10013950 |
E.1.2 | Term | Dysphagia |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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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 determine whether a gel designed to aid tablet administration in patients with swallowing difficulties (dysphagia) effects the absorption of drug from the incorporated tablet. |
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E.2.2 | Secondary objectives of the trial |
To determine if the gel is easy and comfortable to swallow (patient acceptability). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The inclusion criteria for this study are: 1) Healthy 2) Male 3) 18 to 35 years |
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E.4 | Principal exclusion criteria |
The exclusion criteria for this study are: 1) Participants who are studying under the supervision of either Professor Duncan Craig, Professor John Potter or Professor David Wright. 2) Participants who don’t eat or are allergic to gelatin, HPMC, citric acid or potassium sorbate. 3) Patients who suffer with dysphagia or difficulty swallowing. 4) Participants who are allergic to aspirin or any other NSAID. 5) Participants with hypersensitivity to aspirin i.e. attacks of asthma, angioedema, urticaria or rhinitis precipitated by aspirin or any other NSAID 6) Participants who have active peptic ulceration. 7) Participants who have haemophilia or other bleeding disorders. 8) Participants taking aspirin regularly or who have taken in the last 7 days. 9) Participants who are taking other medications, particularly those containing salicylates. 10) Patients with parallel participation in another research study. 11) Any person related to or living with any member of the study team. 12) Any person with language difficulties. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To establish whether the gel swallowing aid has an effect on the absorption of drug from the encapsulated tablet. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Assessment of the last volunteer on the last visit. |
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E.5.2 | Secondary end point(s) |
To assess the volunteer acceptability of the gel swallowing aid device i.e. comfort and ease of swallowing. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Assessment of the last volunteer on the last visit. |
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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 | No |
E.6.8 | Bioequivalence | Yes |
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 | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
IMP with the gel swallowing aid device. |
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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.8.5 | 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 | No |
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 | 2 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |