gastroesophageal reflux disease MedDRA version: 8.1 Level: LLT Classification code 10017885 Term: Gastrooesophageal reflux disease
Conditions
Interventions
Trade Name: Pantozol 40 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Pantoprazole Sodium
CAS Number: 102625-70-7
Other descriptive name: Pantoprazole-Sodium-Sesquihydrate
Concentration unit: m
Sponsors
Nycomed GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 - 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 combina
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: ;Primary end point(s): Time to endoscopic relapse and/or unwillingness to continue due to GERD related symptoms within 6 months. | — |
Countries
Germany
Outcome results
None listed