gastroesophageal reflux disease MedDRA version: 8.1 Level: LLT Classification code 10017885 Term: Gastrooesophageal reflux disease
Conditions
Interventions
Trade Name: Pantozol 40mg
Product Name: Pantoprazole Sodium
Pharmaceutical Form: Tablet
INN or Proposed INN: Pantoprazole Sodium
CAS Number: 102625-70-7
Other descriptive name: Pantoprazole-Sodium-Se
Sponsors
ALTANA Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigation of clinical endpoints for treatment-induced gastroesophageal reflux disease symptom changes;Secondary Objective: ;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. | — |
Countries
Austria, Germany, Hungary
Outcome results
None listed