To measure the formation and retention of alginate rafts in healthy volunteers
Conditions
Interventions
Trade Name: Gaviscon Strawberry Flavour Tablets
Product Name: Gaviscon Strawberry Flavour Tablets
Pharmaceutical Form: Chewable tablet
CAS Number: 9005-38-3
Other descriptive name: SODIUM ALGINATE
Con
Sponsors
Reckitt Benckiser Healthcare (UK) Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Only subjects to whom all of the following conditions apply will be included: 1) Age: = 18 years, = 45 years 2) Sex: male 3) Those with a Body Mass Index of >20kg/m2, =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects to whom any of the following conditions apply must be excluded: 1) Those previously randomised into the study. 2) Those who have suffered a >6kg unexplained weight loss in the previous 6 months. 3) Those who have a history of gastro-oesophageal reflux or active gastrointestinal disease (particularly gastritis, gastroduodenal ulcer, gastrointestinal haemorrhage, mechanical obstruction or perforation) within the last year. 4) Those who show evidence of clinically significant allergic, pulmonary, neurological, renal, hepatic, cardiovascular, psychiatric, metabolic, endocrine or haematological disease. 5) Those who are on a highly restricted salt diet. 6) Those with hypercalcaemia, nephrocalcinosis, recurrent calcium containing renal calculi, or phenylketonuria. 7) Those who have been hospitalised within the previous three months for major surgery or medical illness. 8) Those who have had a clinically significant illness within the previous four weeks. 9) Those who have taken any prescription or non-prescription medication within the previous seven days, prior to the screening visit, which the Principal Investigator considers would interfere with the study. 10) Those who have a history of drug hypersensitivity, which in the opinion of the Principal Investigator, might interfere with the study. 11) Those who have a current or recent (within one year) history of alcohol abuse or abuse of any legal or illegal drugs, substances or solvents. 12) Those who consume abnormal quantities of coffee or tea according to the Principal Investigator’s judgement. 13) Those unable to communicate well with the Principal Investigator (i.e. language problem, poor mental development or impaired cerebral function) in the opinion of the Investigator. 14) Those with difficulty in swallowing or chewing (e.g. those who have loose teeth, dentures, fillings, etc). 15) Those who are known to be hypersensitive or allergic to any of the active substances (e.g. sodium alginate, sodium bicarbonate, calcium carbonate) or any of the excipients 16) Those previously randomised into this study. 17) Those who have participated in a clinical trial in the previous 12 weeks or have taken part in a total of four or more studies in the past 12 months. 18) Those who participated in a study in which radioisotopes were administered or exposure to any radiation other than normal background radiation (e.g. X-rays, handling of radiolabelled materials) within the last 12 months. 19) Those unable in the opinion of the Investigator to comply fully with the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To define an appropriate methodology to assess speed of raft formation. ;Secondary Objective: In addition, the study will compare the amount of time taken for a raft to form with 1) Gaviscon Strawberry Flavour Tablets formulation versus a tablet placebo and 2) Gaviscon Original Aniseed Relief versus a liquid placebo;Primary end point(s): The primary endpoints are the comparisons of the distribution of Investigational Medicinal Product (IMP) in the stomach after 5 minutes post dose for Gaviscon® Strawberry Flavoured Tablets and Gaviscon® Original Aniseed Relief (10ml) versus the respective placebo. The distribution of the IMP in the stomach after 5 minutes is defined as the area under the percentage retention of IMP curve for the upper stomach relative to the area under the percentage retention of IMP curve for the whole stomach at 5 minutes post dose.;Timepoint(s) of evaluation of this end point: Simultaneous anterior and posterior static images of the stomach will be acquired by a dual head gamma camera immediately after the meal is finished, and at 20 minutes after the start time of the meal. images will then be taken for the first five minutes immediately post-dose with 30 second frames. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: • IMP retention corrected for meal retention: the ratio of AUC(IMP) for the whole stomach relative to AUC(meal) for the whole stomach at selected time points. • Distribution of IMP in the stomach: AUC(IMP) for the upper stomach relative to AUC(IMP) for the whole stomach at selected time points. • Distribution of the meal in the stomach: AUC(meal) for the upper stomach relative to AUC(meal) for the whole stomach at selected time points. • Time to half empty the IMP and meal for the whole stomach • The percentage of 111In radioactivity (IMP) in the upper stomach over time for each test product • The percentage of 111In radioactivity (IMP) in the lower stomach over time for each test product • The time taken to form 50% of the complete raft for each test product i.e. time taken to 50% of maximum 111In (IMP) counts in the upper stomach (for Gaviscon® Strawberry Flavoured Tablets and Gaviscon® Original Aniseed Liquid only) • The time taken to form 70% of the complete raft for each test product i.e. time taken to 70% of maximum 111In (IMP) counts in the upper stomach (for Gaviscon® Strawberry Flavoured Tablets and Gaviscon® Original Aniseed Liquid only) • The time taken to form 90% of the compete raft for each test product i.e. time taken to 90% of maximum 111In (IMP) counts in the upper stomach (for Gaviscon® Strawberry Flavoured Tablets and Gaviscon® Original Aniseed Liquid only) • The time taken to form the complete (100%) raft for each test product i.e. time taken to 100% of maximum 111In (IMP) counts in the upper stomach (for Gaviscon® Strawberry Flavoured Tablets and Gaviscon® Original Aniseed Liquid only) • Percentage of raft present in the pre-defined region of interest over the 4 hour period (as described in Section 13.4.3 of the protocol);Timepoint(s) of evaluation of this end point: Following the initial images taken immediately post-dose with 30-second frames for the first five minutes, dynamic im | — |
Countries
United Kingdom
Contacts
Public ContactClinical Project Manager
Reckitt Benckiser Healthcare UK Limited
Outcome results
None listed