E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Gastrooesophageal reflux disease |
|
E.1.1.1 | Medical condition in easily understood language |
Reflux (heartburn and/or acid regurgitation) |
|
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 |
1. To evaluate whether there is a difference in symptom relief in patients prescribed PPI on demand and patients prescribed continuous use of PPI.
2. To evaluate whether the use of electronic tools developed to facilitate clinical trials in primary care result in a higher recruitment rates than paper-based data collection. |
|
E.2.2 | Secondary objectives of the trial |
1. To evaluate whether there is a difference in quality of life and self-rated health in patients prescribed PPI on demand and patients prescribed continuous use of PPI.
2. A) To evaluate whether the use of electronic tools developed to facilitate clinical trials in primary care result in a higher completion rate than paper-based data collection.
B) To evaluate the user acceptance and usability of the electronic tools in GPs and patients. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
* Age 18-65 years
* Predominant GORD cases with heartburn and/or acid regurgitation that need PPI treatment
* PPI responsive
* Ability to complete questionnaires |
|
E.4 | Principal exclusion criteria |
* Known Barrett’s oesophagus
* Known severe oesophagitis (LA C or above)
* Continuous use of NSAID/aspirin
* Prophylactic PPI use to reduce the risk of ulcers in persons being treated with NSAIDs
* PPI treatment to heal an ulcer induced by NSAID treatment in the last 6 months
* PPI treatment for H. pylori eradication in the last 6 months
* Severe disorders other than GORD with a negative impact on quality of life
* Signs of upper gastrointestinal bleeding
* Alarm symptoms: unintentional weight loss/vomiting/difficulties swallowing
* Pregnancy |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Presence and frequency of reflux symptoms as assessed by RDQ (Objective 1)
Recruitment rate (Objective 2) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week 8 (last visit for participant) |
|
E.5.2 | Secondary end point(s) |
Self-rated health (Objective 1)
Quality of life as assessed by SF-12 (Objective 1)
Completion rate (Objective 2) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 8 (last visit for participant) |
|
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) | 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 | 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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
Same medicinal product on demand vs contunous use to be compared |
|
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
| 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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
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
|
End of trial last visit of the last participant undergoing the trial |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 7 |