E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
"Acid-Rebound Hypersecretion" and "Functional dyspepsia" |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064536 |
E.1.2 | Term | Functional dyspepsia |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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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 |
Comparison of number of participants that develop GORD according to the Montreal definition in week 9-12 in the PPI group versus the placebo group.
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E.2.2 | Secondary objectives of the trial |
Comparison of number of participants that develop abdominal pain in week 9-12 in the PPI group versus the placebo group.
Comparison of the total amount of consumed antacida in week 9-12 in the PPI group versus the placebo group.
Number of patients referred from General Practitioner with esophagitis or Barretts' esophagus without symptoms of reflux.
Number of patients referred from General Practitioner with an abnormal pH profile at inclusion without symptoms of reflux.
Number of patients with symptoms of colon irritable at inclusion.
Comparison of treatment response in patients with co-existing colon irritable in the PPI group versus the placebo group. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
18 years + Symptoms of dyspepsia, which GP consider would benefit from PPI treatment. Access to internet.
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E.4 | Principal exclusion criteria |
Signs of severe pathology (extreme weight loss ect.) Symptoms of GORD four weeks before enrolment, according to the Montreal definition. Abnormal pH profile prior to enrolment or at screening. Treatment with PPI or H2-blockers on a regular basis the last year before enrolment Previous surgery on esophagus, stomach or duodenum Use of NSAIDs, antacids, anti-depressives and other analgesics on a regular basis Potential language problems in understanding information and registering symptoms Pregnancy or breast feeding Other diseases which can interfere with the symptom registration (severe congestive heart disease, malignant disease, schizophrenia ect.). No access to internet.
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E.5 End points |
E.5.1 | Primary end point(s) |
Comparison of number of participants that develop GORD according to the Montreal defi-nition in weeks 9-12 in the PPI group versus the placebo group:
- More than mild reflux symptoms (heartburn or acid regurgitation) on more than one day a week or moderate/severe symptoms on one or more days a week.
OR
- Complications to GERD (esophagitis, stricture or Barrett’s esophagus)
OR
- Abnormal pH profile (pH <4 in ≥5.5 % of the time; middle 24-hour period during 48-h monitoring). |
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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 | Yes |
E.6.4 | Safety | Yes |
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 | Information not present in EudraCT |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Cross over in treatment arm only |
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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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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
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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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |