Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Non-erosive Reflux or Gastroesophageal Reflux Disease (BY1023/DE-004)

Study Overview
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Brief Summary
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The aim of the study is to evaluate the effect of pantoprazole on fast symptom reduction in hospitalized patients with NERD (non-erosive reflux disease) or GERD (gastroesophageal reflux disease, Los Angeles [LA] Grade A-D). During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™). The study duration consists of a treatment period of 7 days ± 3 days. Pantoprazole (tablet) will be administered once daily in the morning to patients with NERD or GERD at one dose level for each indication. The study will provide further data on the safety and tolerability of pantoprazole.

Official Title
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Profi-Study: 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

Conditions
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Gastroesophageal Reflux

Intervention / Treatment
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* Drug: Pantoprazole


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Written informed consent Inpatients (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) Main Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Pantoprazole 20 mg | Drug: Pantoprazole<br>* Efficacy of Pantoprazole<br>|
| Active Comparator: 2<br>Pantoprazole 40 mg | Drug: Pantoprazole<br>* Efficacy of Pantoprazole<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 1 day of treatment |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 2 to 7 days of treatment |  | 7 days | 
| Symptom relief rates as measured by ReQuest™ after 7 days of treatment |  | 7 days | 
| Safety |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, Pantoprazole, NERD