E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Gastro-oesophageal reflux disease |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066872 |
E.1.2 | Term | Acid reflux (esophageal) |
E.1.2 | System Organ Class | 100000004856 |
|
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 |
The Gastro-Esophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) (1) score is a validated questionnaire and is commonly used in reflux studies. We will use this questionnaire to ask how patients tolerate stopping their acid reducing medications before reflux testing. We will use this to see if giving them specific instruction about how to use Gaviscon Advance helps patients to tolerate better, versus simply giving them the plain information and allowing them to do it themselves. (1) Velanovich, V. The development of the GERD-HRQL symptom severity instrument. Diseases of the Esophagus. Volume 20, Issue 2, P130-134. April 2007.
|
|
E.2.2 | Secondary objectives of the trial |
We will also use the Gastrointestinal Symptom Score (1) to see if this confirms the finding of the primary question, as well as a questionnaire we have created regarding the patients' adherence to the washout protocol (submitted with additional documents). Sometimes patients know they should stop the medication for the test, but end up taking it anyway as their symptoms are too bad, potentially affecting the results of their test. We will ask the patients to try and truthfully record whether they did manage to stop PPIs or not and reassure them that this information is blinded from the study organisers. In this way we will be able to see if by using the specific instructions we can improve patient’s adherence to the test instructions. The last secondary outcome will be in the measurement of mucosal impedance. At the same time as recording reflux events, the catheter used in the reflux test can take a baseline measurement of mucosal impedance which has been linked to mucosal integrity a |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Adult patients ≥ 18 years age. • Clinical investigation for reflux symptoms (heartburn and/or regurgitation) or dyspepsia (nausea, upper abdominal discomfort, early satiety and/or upper abdominal bloating). • Already established on ≥4 weeks of standard or double dose PPI therapy. • Clinical requirement for pre-investigation PPI washout period. • Is able to communicate well with the study team and comply with the requirements for the entire study. • Has the capacity to understand written English. |
|
E.4 | Principal exclusion criteria |
• Red flag symptoms or urgent (2 week wait referral). • Known Barrett’s oesophagus, reflux oesophagitis, peptic ulcer disease, or upper gastrointestinal malignancy. • Other clinical indication for PPI continuation. • Previous oesophageal or gastric surgery. • Intolerant of alginate preparations. • Patients on a low salt diet. • Unable to tolerate the nasogastric reflux probe for a minimum of 18 hours. • Involvement in any other research currently or within the last four weeks. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Mean change in GERD-HRQL score calculated statistically using a paired t-test. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Exit of final participant. |
|
E.5.2 | Secondary end point(s) |
• Change in gastrointestinal symptom score • PPI and H2-receptor antagonist use • Mean nocturnal baseline impedance measurement |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Exit of final participant. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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 | No |
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 | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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 | 8 |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial days | 29 |