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

• Conditions: gastroesophageal reflux disease; MedDRA version: 9.1Level: LLTClassification code 10017885Term: Gastrooesophageal reflux disease

• Registration Number: EUCTR2005-003485-42-DE
• Lead Sponsor: ycomed GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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 combination with antibiotics for the purpose of the eradication of H. pylori
- Onset or change of psychotropic medication

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, relativ

Study & Design

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