Symptom relief and tolerability of Soraprazan 20 mg qd and Soraprazan 10 mg qd compared to Esomeprazole 20 mg qd in patients with non-erosive gastroesophageal reflux disease (NERD) - SPRINT
- Conditions
- on-Erosive Gastroesophageal Reflux Disease (NERD) as confirmed by endoscopyMedDRA version: 8.1Level: LLTClassification code 10018203Term: GERD
- Registration Number
- EUCTR2006-002779-42-LT
- Lead Sponsor
- ALTANA Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 750
- 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
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 (< 3,5 mmol/L)
- Severe or unstable 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 (except isolated allergy to penicillin or related antibiotics)
- Alcohol, drug or medication abuse within the past year
- Clinically relevant abnormal vital signs suggesting an underlying disease and requiring further clinical evaluation
- 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,
* intrauterine contraceptive devices,
* or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
Please note that female patients who are surgically sterilized / hysterectomized, or post-menopausal > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method