Bioequivalence study of a gel swallowing aid

• Register: ISRCTN
• Last refreshed on: 30 July 2018
• Main ID: ISRCTN13972867
• Date of registration: 08/11/2012
• Prospective Registration: Yes
• Primary sponsor: Norfolk and Norwich University Hospital NHS Trust (UK)
• Public title: Bioequivalence study of a gel swallowing aid
• Scientific title: Bioequivalence study of a gel swallowing aid: a randomised study
• Date of first enrolment: 21/01/2013
• Target sample size: 12
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN13972867
• Study type: Interventional
• Study design: Randomised; Interventional; Design type: Process of Care, Treatment (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: John Potter

Key inclusion & exclusion criteria

Inclusion criteria: Healthy male volunteers aged 18 to 35
Exclusion criteria: 1. Participants who don?t eat or are allergic to gelatin, hydroxypropyl methylcellulose (HPMC), citric acid or potassium sorbate
2. Patients who suffer with dysphagia or difficulty swallowing
3. Participants who are allergic to aspirin or any other Nonsteroidal anti-inflammatory drugs (NSAIDs)
4. Participants with hypersensitivity to aspirin i.e. attacks of asthma, angioedema, urticaria or rhinitis precipitated by aspirin or any other NSAID
5. Participants who have active peptic ulceration.
6. Participants who have haemophilia or other bleeding disorders
7. Participants taking aspirin regularly or who have taken in the last 7 days
8. Participants who are taking other medications, particularly those containing salicylates
9. Patients with parallel participation in another research study
10. Any person related to or living with any member of the study team
11. Any person with language difficulties

Age minimum:
Age maximum:
Gender: Male

Health Condition(s) or Problem(s) studied

Bioequivalence study
Not Applicable

Intervention(s)

Each volunteer will be administered an aspirin tablet both with and without the gel swallowing aid on two separate occasions. Six blood samples will be taken over the course of two hours on each occasion. Volunteers will also be asked to complete a short questionnaire relating to the ease and comfort of swallowing the tablet in each scenario.

Twelve volunteers will be recruited from the University of East Anglia and the Norfolk and Norwich University Hospital to swallow a tablet (300mg aspirin) encapsulated within the gel, and also the tablet without the gel. The volunteers will be asked to provide blood samples at time points along the absorption process to determine the blood serum concentration of aspirin metabolites. The effect on platelets will also be determined. It is envisaged that the study will last a total of 6 hours (3 hours on two separate occasions) for each volunteer. The gels will be prepared up to twenty four hours in advance in the hospital pharmacy and stored at room temperature.

Primary Outcome(s)

Safety of the gel i.e. ?to ensure the gel can be administered safely without unacceptable adverse effects?.

Secondary Outcome(s)

To assess the acceptability of the gel swallowing aid using a questionnaire relating to ease and comfort of swallowing the tablet with and without the gel.

Secondary ID(s)

13464

Source(s) of Monetary Support

Medical Research Council (MRC) (UK)

Ethics review

Status:
Approval date:
Contact:

NRES Committee East of England ? Cambridge East, 18th June 2012, ref: 12/EE/0097/AM01

Results

• Results available: Yes
• Date Completed: 31/03/2013