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: 14.1 Level: PT Classification code 10013950 Term: Dysphagia System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Actavis
Product Name: Aspirin
Pharmaceutical Form: Tablet
INN or Proposed INN: Aspirin
CAS Number: 50-78-2
Other descriptive name: Acetylsalicylic Acid
Concentration unit: mg milligram(s)
Sponsors
Norfolk and Norwich University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Contacts
Public ContactAndrews
Norfolk and Norwich University Hospitals NHS Foundation Trust
Outcome results
None listed