| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Symptoms thought to be gastroesophageal reflux disease (GERD)-related |
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| 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 compare the efficacy of three different long-term treatment strategies in primary care setting, separately within different levels of symptom load according to clinical judgement at baseline (Visit 1) in subjects with symptoms thought to be GERD-related using the number of ‘treatment failures’ as primary outcome variable. |
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| E.2.2 | Secondary objectives of the trial |
1. To evaluate whether the Reflux Disease Questionnaire (RDQ) – used in primary care setting - adds value to clinical judgement in assessing baseline symptom load and thus facilitates the decision on appropriate acute and maintenance treatment strategy in patients with reflux symptoms
2. To assess the additional impact of a concomitant low dose acetylsalicylic acid (ASA) therapy during acute and maintenance phase with regard to efficacy.
3. To evaluate whether there is a difference between treatment strategies with regard to patient satisfaction during maintenance phase using the GERD Impact Scale
4. To assess resource utilization and days absent from work due to GERD symptoms related to ‘treatment failures’ during the maintenance phase.
5. To assess the impact of GERD symptoms on patient-reported utility values.
6. To assess the impact of GERD symptoms on patient-reported productivity while at work and while carrying out daily non-work activities.
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| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria |
1. Signed informed consent from the subject prior to conducting any study-related procedures.
2. Males or females aged between 18 and 50 years.
3. Subjects who seek medical advice in primary care for symptoms thought to be GERD related (GERD is a condition which develops when the reflux of stomach content causes troublesome symptoms and / or complications).
4. Subjects should be eligible for empirical treatment for up to 16 weeks with either esomeprazole and / or rescue medication (antacids) according to physician’s judgement.
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| E.4 | Principal exclusion criteria |
1. Subjects with any clinical GERD diagnosis / treatment (PPI, H2-receptor antagonists) within last 3 months prior to Visit 1.
2. Subjects with a history of severe esophagitis (i.e. LA grade C or D) or known other complications (e.g. Barrett‘s esophagus, stricture).
3. Previous anti-reflux surgery, or any form of upper gastrointestinal resective surgery.
4. Subjects with alarm symptoms such as unintentional weight loss, dysphagia, disturbed food passage, persistent vomiting, haematemesis, melena and jaundice.
5. Any other signs / suspicions indicating serious or malignant disease.
6. Subjects with dominant symptoms suggestive of peptic ulcer disease or dyspepsia (functional dyspepsia is defined as persistent or recurrent pain or discomfort centred in the upper abdomen [Rome II criteria]).
7. Subjects with chronic or recurrent abdominal pain associated with a chronic or recurrent bowel disturbance and / or bloating, that in the opinion of the investigator is likely to be due to irritable bowel syndrome, or two or more of the following criteria:
- visible abdominal distention,
- pain relieved by a bowel action,
- more frequent stools with the onset of pain,
- looser stools with the onset of pain,
- rectal passage of mucus,
- a sensation of incomplete defecation.
8. Any significant past or current disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study or subject’s ability to participate in the study.
9. Subjects with a need for a NSAID therapy or an ASA therapy with a daily dose > 325 mg.
10. Subject judged by investigator not to be capable to understand and complete PRO Questionnaires reliably.
11. Subjects taking contraindicated concomitant medication according to local Market Data Sheet (MDS).
12. Pregnancy or lactation. Women of childbearing potential will be required to use an effective method of birth control for the duration of the study to prevent pregnancy. Acceptable methods include implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or sterilisation (including vasectomy).
13. Subjects with a known hypersensitivity to any component of esomeprazole or rescue medication used in the study.
14. Planned donation of blood during the study participation.
15. Planned hospitalization during the study participation.
16. History of alcohol or drug abuse in the last two years or any condition associated with poor compliance, including expected non-cooperation, as judged by the investigator.
17. Participation in another clinical study of any investigational drug within 30 days prior to start or during the course of the study.
18. Previous enrolment in this study.
19. Involvement in the planning and conduct of the study (applies to both, AstraZeneca staff or staff at the study site).
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| E.5 End points |
| E.5.1 | Primary end point(s) |
| The number of "treatment failures" during the maintenance phase is the primary outcome variable related to the primary study objective |
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | Information not present in EudraCT |
| E.6.2 | Prophylaxis | Information not present in EudraCT |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Information not present in EudraCT |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Information not present in EudraCT |
| E.6.7 | Pharmacodynamic | Information not present in EudraCT |
| E.6.8 | Bioequivalence | Information not present in EudraCT |
| E.6.9 | Dose response | Information not present in EudraCT |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | Information not present in EudraCT |
| E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
| E.6.13 | Others | Information not present in EudraCT |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
| E.7.1.1 | First administration to humans | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
| E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
| 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 | Yes |
| 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.8.5 | The trial involves multiple Member States | Yes |
| 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 | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| 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 study is defined as date of database lock, which is the time point after which no subject will be exposed to study related activities. |
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 3 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 3 |
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