A Scintigraphy Study of test product vs Gaviscon® DA Tablets
Research type
Research Study
Full title
A randomized, open-label, 2-treatment crossover study to compare by scintigraphy, the antireflux activity of the to-be- registered product (250 mg sodium alginate/187.5 mg calcium carbonate/106.5 mg sodium hydrogen carbonate) chewable Tablets versus registered Gaviscon Double Action Tablets, in healthy adult subjects.
IRAS ID
215107
Contact name
Annelize Koch
Contact email
Sponsor organisation
Sanofi-Aventis
Eudract number
2015-000764-34
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
WHO universal trial number, U1111-1182-1864
Duration of Study in the UK
0 years, 3 months, 5 days
Research summary
This is phase I healthy volunteer study of an unregistered test product, which is being developed for the treatment of acid related symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion.
The study has a two way crossover design, therefore, each subject will receive the test investigational medicinal product and a reference product at different treatment periods. The reference product will be Gaviscon Double action tablets. Gaviscon double action chewable tablets have been marketed since 2006 on a general sales license and helps provide relief from indigestion and heartburn.
A total of 34 subjects (male and female) will be recruited to ensure 30 subjects complete the study. As this study uses a crossover design all subjects will receive both the test and reference product, however the order in which they receive the product will be randomized.
The key objective of this study is to compare the test and reference product. This will be done using a technique called gamma scintigraphy. Gamma scintigraphy is used to track the movement of radiolabelled drugs inside the body, to allow the assessment of gastric retention of alginate rafts. Aliginate rafts are a layer of gel that floats above the stomach content and acts as a barrier stopping acid reflux. Therefore, this study will assess how long it takes for the stomach to empty the alginate rafts that have formed following administration of the product.
The eligible population are: healthy male and female volunteers; aged between 18 and 55 years; non-smokers or smokers limited to 5 cigarettes per day. Eligibility will be determined by screening tests at Simbec Research.Participation in the trial will last for about 6 weeks (from first screening visit to final end of study visit).
REC name
Wales REC 1
REC reference
16/WA/0346
Date of REC Opinion
7 Dec 2016
REC opinion
Favourable Opinion