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 |
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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 |
Investigation of clinical endpoints for treatment-induced gastroesophageal reflux disease symptom changes |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
· Written informed consent by the patient for study participation, prior to protocol specific procedures · Patients of at least 18 years of age · History of GERD-related symptoms for at least 6 months prior to inclusion into the study · Heartburn (defined as a burning feeling, rising from the stomach or lower part of the chest up towards the neck) on at least 3 days during the last week prior to inclusion into the study as assessed by the investigator · Acid complaints on at least 3 days during the last week prior to inclusion into the study as assessed by the investigator · Endoscopically confirmed gastroesophageal reflux esophagitis (Grade A to D classification determined via the Los Angeles classification system) or symptom-based diagnosis of endoscopic-negative GERD (enGERD) · Patients whose compliance is expected to be high with respect to the completion of ReQuest™ and 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 · Acute peptic ulcer and/or ulcer complications · Pyloric stenosis · Symptoms of irritable bowel syndrome that dominate the clinical picture · 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 investigational medicinal product · 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 post-menopausal > 2 years, or who are not using any other method considered sufficiently reliable by the investigator in individual cases
Previous medication: · PPIs during the last 7 days before the start of the study · H2-receptor antagonists or prokinetics during the last 2 days before the start of the study · Sucralfate, antacids, 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 7 days before the start of the study
Concomitant medication: · PPIs (except investigational medicinal product), H2-receptor antagonists, prokinetics, sucralfate, antacids, 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, stop, or change of psychotropic medication
Others: · Patients who are expected to be non-compliant and/or not cooperative · Participation in a clinical study within 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) |
Primary variable of the study is the misclassification rate as defined below:
For each patient the following two assessments will be made: · Investigator-assessed heartburn · Symptom assessment by ReQuest™-GI
A patient will be defined as misclassified if one of the following two statements is true: · The patient is below the predefined ReQuest™-GI GERD symptom threshold (i.e., 1.60 based on the 95% percentile) on all of the 3 consecutive days prior to day 14 and is not heartburn free (investigator-assessed) on all of the 7 consecutive days prior to day 14. · The patient is above the predefined ReQuest™-GI GERD symptom threshold on all of the 3 consecutive days prior to day 14 and is heartburn free (investigator-assessed) on all of the 7 consecutive days prior to day 14.
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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 | 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 | Information not present in EudraCT |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | 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 | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 7 |