Non-Erosive Gastroesophageal Reflux Disease (NERD) as confirmed by endoscopy 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: BYK6135
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 NERD (non-erosive gastroesophageal reflux disease) - History of frequent episodes of GERD-related symptoms during the last 3 months prior to inclusion into the study - 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) - Endoscopically confirmed gastroesophageal reflux esophagitis (LA Grade A-D) - 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 - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the superiority of Soraprazan 20 mg qd and Soraprazan 10 mg qd compared to Esomeprazole 20 mg qd in symptom relief over the first 3 days of treatment measured by the ReQuestTM in patients suffering from NERD.;Secondary Objective: ;Primary end point(s): Symptom relief (i.e. patient below symptom threshold) measured by the subscale ReQuestTM-GI over the first 3 days of treatment | — |
Countries
Lithuania
Outcome results
None listed