E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Dyspeptic Symptoms GERD (gastroesophageal reflux disease), NERD (non erosive reflux disease), ERD (erosive reflux disease), Barretts esophagus, Adeno-CA of the esophagus |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10017885 |
E.1.2 | Term | Gastrooesophageal reflux disease |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10004137 |
E.1.2 | Term | Barrett's oesophagus |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001173 |
E.1.2 | Term | Adenocarcinoma of esophagus |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10013949 |
E.1.2 | Term | Dyspeptic signs and symptoms |
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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 |
•To determine the mRNA expression signatures of genes associated with non-erosive and erosive esophagitis, Barrett’s esophagus and esophageal adenocarcinoma. •To determine notable proliferation and differentiation markers (e.g. KI 67, CDX, SOX and SPEM) in patients with non-erosive and erosive esophagitis, Barrett’s esophagus and esophageal adenocarcinoma.
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E.2.2 | Secondary objectives of the trial |
•To determine the relationship between histological signs of (GERD) in squamous epithelium (dilatation of intercellular spaces, hyperplasia of basal cell layer, elongation of papillae) and the above mentioned mRNA expression signatures and proliferation and differentiation markers. •To determine the relationship between the severity of gastroesophageal acid reflux as measured by 48-hour pH-metry and the above mentioned mRNA expression signatures and proliferation and differentiation markers. •To determine the relationship between responsiveness to proton pump inhibitor (PPI) treatment and the above mentioned mRNA expression signatures and proliferation and differentiation markers.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female, age >18 years - Ability to provide informed consent - Signed written informed consent - Dyspeptic symptoms. Classification and stratification according to table "Target subject population" on page 4 and 9 of the protocol version 1.0 dated 05.06.2007 |
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E.4 | Principal exclusion criteria |
- Inability to provide informed consent - History of gastrointestinal disorders other than GERD that may significantly affect the incidence and/or the assessment of reflux episodes (e.g. esophageal varices, active ulcer disease, gastrointestinal motility disorders) - History of clinically significant cardiac or renal disease - Chronic or acute inflammatory condition or connective tissue disorder (e.g. vasculitis, lupus, sepsis, pneumonia) - Intake of drugs with major interference with esomeprazole (Nexium®) or with oesophageal or gastric function - Any incompatibility against proton pump inhibitors - pregnancy or lactation - alcohol or drug abuse
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E.5 End points |
E.5.1 | Primary end point(s) |
- Endoscopy with biopsies for histology and molecular analyses at visit 4. - Withdrawal of consent by the patient - Any AE which do not allow continuation of the study according to the investigators opinion - Non-Compliance of a patient - Discontinuation according to the investigators opinion, if continuation is not in the best interest of a patient. |
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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 | Yes |
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 | Yes |
E.6.11 | Pharmacogenomic | Yes |
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 | 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) | 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 | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
Parallel group. Controll group 1 (Dyspeptic Symptoms) |
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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 | 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
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- Endoscopy with biopsies for histology and molecular analyses at visit 4 of the last patient enrolled.
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |