Endoscopically confirmed gastroesophageal reflux disease (GERD), Grade A-D according to Los Angeles (LA) classification MedDRA version: 8.1 Level: LLT Classification code 10018203 Term: GERD
Conditions
Interventions
Product Name: Soraprazan 10 mg film coated tablets,encapsulated
Product Code: BY359
Pharmaceutical Form: Capsule*
INN or Proposed INN: Soraprazan
CAS Number: 261944-46-1
Current Sponsor code: BYK61359
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 being 18 - 65 years of age · Endoscopically confirmed gastroesophageal reflux esophagitis (Grade A-D classification, determined via the Los Angeles classification system, including photo documentation) · Frequent episodes of acid-related symptoms defined as on at least 4 days during the last week prior to inclusion into the study 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) no 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 finding · 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 · Myocardial infarction within the previous 3 months prior to inclusion into the study or any unstable or severe heart disease (e.g. clinically overt heart failure (NYHA III-IV), unstable angina pectoris, severe uncontrolled arterial hypertension) · Subjects with percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within the last 3 months prior to inclusion into the study · History of drug-induced Torsade de Pointes, or presence of a familial long QT syndrome · History or evidence of clinically relevant arrhythmias (atrial fibrillation, frequent and complex extrasystoles, ventricular tachycardia, ventricular pre-excitation syndromes) · Relevant serum hypokalemia ( 2 years are not considered as being of childbearing potential. Previous medication · Intake of proton pump inhibitors (PPIs) during the previous 14 days prior to the start of the study · H2-receptor antagonists or 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the superiority of Soraprazan 20 mg qd compared to Soraprazan 10 mg qd in healing rates over 4 and 8 weeks of treatment in patients suffering from GERD, Grade A-D ;Secondary Objective: Endoscopically confirmed healing and symptom relief of Soraprazan 20 mg qd and Soraprazan 10 mg qd compared to Esomeprazole 40 mg qd after 4 and 8 weeks of treatment.;Primary end point(s): Endoscopically proven healing of Soraprazan 20 mg qd and Soraprazan 10 mg qd after 4 weeks and 8 weeks of treatment in patients suffering from GERD, Grade A-D | — |
Countries
Lithuania
Outcome results
None listed