| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| To measure the formation and retention of alginate rafts in healthy volunteers |
|
| E.1.1.1 | Medical condition in easily understood language |
| Reflux of the stomach contents into the oesophagus |
|
| E.1.1.2 | Therapeutic area | Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] |
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To define an appropriate methodology to assess speed of raft formation. |
|
| E.2.2 | Secondary objectives of the trial |
| 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 |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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, <27kg/m2.
4) Those who are willing to abstain from consuming alcohol from 48 hours prior to each dosing day.
5) Those who are willing to abstain from smoking tobacco whilst at the study centre.
6) Those who are willing to consume both the standard radiolabelled meal, which contains scrambled eggs and the radiolabelled study drug on each dosing day.
7) Subjects who have given written informed consent. |
|
| E.4 | Principal 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. |
|
| E.5 End points |
| E.5.1 | 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. |
|
| E.5.1.1 | 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. |
|
| E.5.2 | 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) |
|
| E.5.2.1 | 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 images with 60s frames will be acquired from five to fifteen minutes. Single frames of
60s duration will be acquired at twenty minutes and then at 20 minute intervals to four hours after study medication administration. |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | No |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | Yes |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 2 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 2 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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