Symptom reduction in hospitalized patients suffering from symptomatic non-erosive or erosive gastroesophageal reflux disease treated with pantoprazole 20 or 40 mg o.d. for 7 days - PROFI

• Conditions: Symptomatic non-erosive reflux disease (NERD) or erosive gastroesophageal reflux disease (GERD); MedDRA version: 8.1Level: LLTClassification code 10017885Term: Gastrooesophageal reflux disease

• Registration Number: EUCTR2005-004856-11-DE
• Lead Sponsor: ALTANA Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

- Written informed consent by the patient for study participation, prior to protocol specific procedures
- Inpatients of at least 18 years of age (hospitalization during the entire study period is mandatory)
- Symptomatic (heartburn, acid regurgitation or dysphagia for at least 1 day since admission to the hospital) non-erosive reflux disease (NERD) or erosive gastroesophageal reflux disease (GERD, LA grade A-D)

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

Signs, indicating other gastrointestinal diseases:
- Known 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
- Known 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 as considered by the investigator
- 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 and not explainable by medical history
- Severe psychiatric or neurologic disorders as considered by the investigator

Special restrictions for female patients:
- Pregnant or nursing female patients
- Female patients of childbearing potential, who are not using and not willing to use 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 any other criteria considered sufficiently reliable by the investigator in individual case

Previous medication:
- Proton pump inhibitors (PPIs) during the last 3 days before intake of study medication
- H2-receptor antagonists or prokinetics : stop at Visit V0
- Sucralfate, bismuth preparations or other substances, which may have an influence on the relief of acid-related symptoms: stop at Visit V0
- Any medication for the purpose of the eradication of H. pylori during the last 28 days before intake of study medication

Concomitant medication
- Proton pump inhibitors (PPIs, except study medication), H2-receptor antagonists, antacids, prokinetics, sucralfate, bismuth preparations or other substances, which may have an influence on the relief of acid-related symptoms
- Onset or change in the first two days of the study of systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors
- Ketoconazole or other drugs with pH-dependent absorption
- Proton pump inhibitors (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 co-operative
- 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 contractual

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To prove fast symptom reduction in hospitalized patients suffering from NERD or GERD after 1 day of treatment with pantoprazole 20 mg (NERD) or with pantoprazole 40 mg (GERD A-D).;Secondary Objective: ;Primary end point(s): The primary variable of this study is the symptom reduction from reflux disease related symptoms measured as assessed by ReQuest TM -GI after 1 day of treatment.