Gastroesophageal reflux disease MedDRA version: 5.0 Level: llt Classification code 10038263
Conditions
Interventions
Trade Name: Pantozol 40 mg
Product Name: Pantozol 40 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Pantoprazole
CAS Number: 102625-70-7
Current Sponsor code: BY1023
Other descriptive name: Panto
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 - Outpatients of at least 18 years of age - Reflux disease related symptoms for at least 12 weeks, which need not be consecutive, in the previous 12 months or endoscopically confirmed reflux esophagitis grade A to D according to LA-classification 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 - 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 - Abnormal laboratory parameters and vital signs considered as clinically relevant 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 and prokinetics during the last 7 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 150 mg/d Concomitant medication: - PPIs (except study medication), H2-receptor antagonists, prokinetics, sucralfate, misoprostol and bismuth preparations - 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 150 mg/d - Ketoconazole or other drugs with pH dependent absorption - PPIs in combination with antibiotics for the purpose of the eradication of H. pylori Others: - Patients who are expected to be non-compliant and/or not cooperative - Participation in a clinical study within the last 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, relative 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the complete reflux disease remission rates after 4, 8 and 12 weeks of treatment with pantoprazole 40 mg o.d. and to estimate the time to reach complete remission based on the Kronberg Los Angeles classification ;Secondary Objective: ;Primary end point(s): Primary variable of the study is the complete reflux disease remission rate after 8 weeks of treatment defined as symptomatic remission measured by the ReQuest™-GI score and endoscopic remission | — |
Countries
Germany, Hungary
Outcome results
None listed