Endoscopic healing and tolerability of Soraprazan 20 mg qd compared to Soraprazan 10 mg qd and to Esomeprazole 40 mg qd in patients suffering from GERD Grade A-D (LA classification) - SPEED

• Conditions: Endoscopically confirmed gastroesophageal reflux disease (GERD), Grade A-D according to Los Angeles (LA) classification; MedDRA version: 8.1Level: LLTClassification code 10018203Term: GERD

• Registration Number: EUCTR2006-002777-42-LT
• Lead Sponsor: ALTANA Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 750

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

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 (< 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 dosages up to 150 mg

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified