EUCTR2005-004856-11-DE
Active, not recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Symptomatic non-erosive reflux disease (NERD) or erosive gastroesophageal reflux disease (GERD)
- Sponsor
- ALTANA Pharma AG
- Enrollment
- 350
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Not Applicable
Observational study of hospitalized patients with heart failure at the Japanese Red Cross Wakayama Medical CenterJPRN-UMIN000053982Japanese Red Cross Wakayama Medical Center1,000
Completed
Not Applicable
Effect of PHARMacological treatment in hospitalized patients with Heart FailureHeart failureJPRN-UMIN000043293Department of Medical Science and Cardiorenal Medicine, Yokohama City University254
Completed
Phase 3
COVID-19: Reducing Symptoms and Hospitalization rates by use of Azelastine Nasal spray in patients suffering from COVID-19 in Early stagesTreatment of COVID-19 patientsDRKS00028829RSAPHARM Arzneimittel GmbH272
Not yet recruiting
Not Applicable
The effects of Posture and Continuous Positive Airway Pressure (CPAP) on lung function in patients recovering from an acute exacerbation of heart failureHeart FailureCardiovascular - Other cardiovascular diseasesRespiratory - Other respiratory disorders / diseasesACTRN12610000556044Professor Matthew Naughton100
Not yet recruiting
Not Applicable
Association of physical symptoms during hospitalization after severe illness with walking ability at dischargecritically ill patientsJPRN-UMIN000040135agasaki University hospital200