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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 660

Inclusion Criteria

· 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
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:
· 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
· 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 investigational medicinal product
· Alcohol, drug or medication abuse within the past year
· Clinically relevant abnormal laboratory values and vital signs suggesting an underlying disease and requiring further clinical evaluation (as assessed by the investigator)
· 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, or intrauterine contraceptive devices, unless they are surgically sterilized/hysterectomized, or post-menopausal > 2 years, or who are not using any other method considered sufficiently reliable by the investigator in individual cases

Previous medication:
· PPIs during the last 7 days before the start of the study
· H2-receptor antagonists or prokinetics during the last 2 days before the start of the study
· Sucralfate, antacids, bismuth preparations or other substances, which may have an influence on the relief of acid-related symptoms during the last 2 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 163 mg/d
· Dyspepsia-inducing drugs, e.g., bisphosphonates, misoprostol, for more than 3 consecutive days during the last 7 days before the start of the study

Concomitant medication:
· PPIs (except investigational medicinal product), H2-receptor antagonists, prokinetics, sucralfate, antacids, bismuth preparations or other substances, which may have an influence on the relief of acid-related symptoms
· Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (> 5 days on demand but not more than 3 consecutive days) except regular intake of acetylsalicylic acid

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Investigation of clinical endpoints for treatment-induced gastroesophageal reflux disease symptom changes;Secondary Objective: ;Primary end point(s): Primary variable of the study is the misclassification rate as defined below:<br><br>For each patient the following two assessments will be made:<br>· Investigator-assessed heartburn<br>· Symptom assessment by ReQuest™-GI<br><br>A patient will be defined as misclassified if one of the following two statements is true:<br>· The patient is below the predefined ReQuest™-GI GERD symptom threshold (i.e., 1.60 based on the 95% percentile) on all of the 3 consecutive days prior to day 14 and is not heartburn free (investigator-assessed) on all of the 7 consecutive days prior to day 14.<br>· The patient is above the predefined ReQuest™-GI GERD symptom threshold on all of the 3 consecutive days prior to day 14 and is heartburn free (investigator-assessed) on all of the 7 consecutive days prior to day 14.<br>

Secondary Outcome Measures

Name	Time	Method

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