Investigation of clinical endpoints for treatment-induced gastroesophageal reflux disease (GERD) symptom changes - COMPETITIO

ALTANA Pharma AG0 sites660 target enrollmentMay 4, 2006

Overview

No summary available.

Registry

who.int

Start Date

May 4, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•· Written informed consent by the patient for study participation, prior to protocol specific procedures
•· Patients of at least 18 years of age
•· History of GERD\-related symptoms for at least 6 months prior to inclusion into the study
•· Heartburn (defined as a burning feeling, rising from the stomach or lower part of the chest up towards the neck) on at least 3 days during the last week prior to inclusion into the study as assessed by the investigator
•· Acid complaints on at least 3 days during the last week prior to inclusion into the study as assessed by the investigator
•· Endoscopically confirmed gastroesophageal reflux esophagitis (Grade A to D classification determined via the Los Angeles classification system) or symptom\-based diagnosis of endoscopic\-negative GERD (enGERD)
•· Patients whose compliance is expected to be high with respect to the completion of ReQuest™ and GERDyzer™ according to the assessment of the investigator
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•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
•· 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:
•· 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