Treatment response in patients with symptoms due to gastroesophageal reflux disease either with or without esophagitis treated with pantoprazole sodium 40 mg o.d. over 8 weeks - REAL LIFE

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 2000

Inclusion Criteria

- Written informed consent by the patient for study participation, prior to protocol specific procedures
- Outpatients of at least 18 years of age (21 years in Argentina)
- Patient considered by the investigator to have symptoms due to gastroesophageal reflux disease
- Patients whose compliance is expected to be high with respect to the completion of the questionnaires and diaries (ReQuest™, GERDyzer™, HADS, TSS) 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
- 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 study medication
- 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
- 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 who are not using any other method considered sufficiently reliable by the investigator in individual cases

Previous medication:
- PPIs during the last 10 days before 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 163 mg/d

Concomitant medication:
- PPIs (except study medication), H2-receptor antagonists, prokinetics, sucralfate, misoprostol, 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 in dosages up to 163 mg/d
- Ketoconazole or other drugs with pH-dependent absorption
- PPIs in combinatio

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of the present study is the identification of factors (e.g. symptom patterns and symptom scores) determining the response to treatment with pantoprazole 40 mg o.d. as measured by different methods (e.g. ReQuest™ questionnaire, patient and investigator assessment).;Secondary Objective: ;Primary end point(s): The primary variable of this study is the response to treatment with pantoprazole 40 mg o.d. at week 8 as measured by ReQuest™-GI in relation to various response factors as measured by ReQuest™ and its subscales

Secondary Outcome Measures

Name	Time	Method

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