Dyspeptic Symptoms GERD (gastroesophageal reflux disease), NERD (non erosive reflux disease), ERD (erosive reflux disease), Barretts esophagus, Adeno-CA of the esophagus MedDRA version: 9.1 Level: PT Classification code 10017885 Term: Gastrooesophageal reflux disease MedDRA version: 9.1 Level: PT Classification code 10004137 Term: Barrett's oesophagus MedDRA version: 9.1 Level: LLT Classification code 10001173 Term: Adenocarcinoma of esophagus MedDRA version: 9.1 Level: HLT Classification co
Conditions
Interventions
Trade Name: Nexium mups 40 mg
Product Name: Esomeprazole
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: ESOMEPRAZOLE
CAS Number: 119141887
Current Sponsor code: Esomeprazole
Concent
Sponsors
Otto-von-Guericke University
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •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. ;Secondary Objective: •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. ;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. | — |
Countries
Germany
Outcome results
None listed