Study to investigate the effect of a gel swallowing aid on the absorption of an enclosed tablet.

Phase 1

• Conditions: 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.; MedDRA version: 14.1Level: PTClassification code 10013950Term: DysphagiaSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2011-005208-14-GB
• Lead Sponsor: orfolk and Norwich University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-02
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

The inclusion criteria for this study are:
1) Healthy
2) Male
3) 18 to 35 years
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: To determine if the gel is easy and comfortable to swallow (patient acceptability).;Primary end point(s): To establish whether the gel swallowing aid has an effect on the absorption of drug from the encapsulated tablet.;Timepoint(s) of evaluation of this end point: Assessment of the last volunteer on the last visit.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To assess the volunteer acceptability of the gel swallowing aid device i.e. comfort and ease of swallowing.;Timepoint(s) of evaluation of this end point: Assessment of the last volunteer on the last visit.