E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
gastroesophageal reflux disease |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10017885 |
E.1.2 | Term | Gastrooesophageal reflux disease |
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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 |
Evaluation of complete remission rates in patients with erosive GERD treated with pantoprazole 40 mg over 4/8/12/16 weeks and demonstration that patients in complete remission will have less endoscopic relapses and/or discontinue the study more seldom and have an increased quality of life compared to classically healed patients. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Written informed consent by the patient for study participation, prior to protocol specific procedures - Outpatients of at least 18 years of age - Endoscopically confirmed gastroesophageal reflux esophagitis (Grade A-D classification determined via the Los Angeles classification system) - Patients whose compliance is expected to be high with respect to the completion of the questionnaires (ReQuest™, GERDyzer™) according to the assessment of the investigator
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E.4 | Principal exclusion criteria |
Signs, indicating other gastrointestinal diseases: - Zollinger-Ellison syndrome or other gastric hypersecretory condition - Previous acid-lowering surgery or other surgery of the esophagus and/or upper gastrointestinal tract (exception: polypectomy and cholecystectomy) - On initial endoscopy, presence of obstructive esophageal strictures, Schatzki’s ring, esophageal diverticula, esophageal varices, achalasia or Barrett‘s esophagus with known high-grade dysplasia or longer than 3 cm - Symptomatic GERD without any endoscopic findings - Acute peptic ulcer and/or ulcer complications - Pyloric stenosis - Inflammatory bowel diseases
Other concomitant diseases: - Severe or unstable cardiovascular (e.g., severe angina pectoris, postmyocardial infarction and ventricular extrasystoles), pulmonary, or endocrine disease; clinically significant renal or hepatic disease or dysfunction; hematologic disorder; any other clinically significant medical condition that could increase the risk to the study participant - Malignant disease of any kind during the previous 5 years except for successfully treated skin (basal or squamous cell) cancer - Tendency to react allergically to drugs, especially with known hypersensitivity to one of the compounds of the study medication - Alcohol, drug or medication abuse within the past year - Clinically relevant abnormal laboratory values and vital signs suggesting an underlying disease and requiring further clinical evaluation (as assessed by the investigator) - Severe psychiatric or neurologic disorders
Special restrictions for female patients: - Pregnant or nursing female patients - Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized / hysterectomized or who are not using any other method considered sufficiently reliable by the investigator in individual cases
Previous medication: - PPIs during the last 14 days before the start of the study - H2-receptor antagonists, prokinetics during the last 7 days before the start of the study - Sucralfate, bismuth preparations or other substances, which may have an influence on the relief of acid-related symptoms during the last 2 days before the start of the study - Any medication for the purpose of the eradication of H. pylori during the last 28 days before the start of the study - Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (> 5 days on demand but not more than 3 consecutive days) during the last 28 days before the start of the study; except regular intake of acetylsalicylic acid in dosages up to 163 mg/d - Dyspepsia-inducing drugs, e.g., bisphosphonates, misoprostol, for more than 3 consecutive days during the last 14 days before the start of the study
Concomitant medication: - PPIs (except study medication), H2-receptor antagonists, prokinetics, sucralfate, bismuth preparations or other substances, which may have an influence on the relief of acid-related symptoms - Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (> 5 days on demand but not more than 3 consecutive days) except regular intake of acetylsalicylic acid in dosages up to 163 mg/d - Ketoconazole or other drugs with pH-dependent absorption - PPIs in combination with antibiotics for the purpose of the eradication of H. pylori - Onset of dyspepsia-inducing drugs, e.g., bisphosphonates, misoprostol, for more than 3 consecutive days - Onset of psychotropic medication
Others: - Patients who are expected to be non-compliant and/or not cooperative - Participation in a clinical study within the 30 days prior to the start of the study - Patients who have participated already in this study - Patients who are employees at the investigational site, relatives or spouse of the investigator - Any donation of germ cells, blood, organs, or bone marrow during the course of the study - Patients who are not contractually capable
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to endoscopic relapse and/or unwillingness to continue due to GERD related symptoms within 6 months. |
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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 | 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 |
classical healing concept vs complete remission concept |
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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 | 12 |
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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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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 | 2 |
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 | 2 |