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

Condition(s) targeted: Gastroesophageal Reflux

Intervention: Pantoprazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Nycomed

Official(s) and/or principal investigator(s):
Joachim Mössner, Prof., Principal Investigator, Affiliation: Universitätsklinikum Leipzig, Leipzig, Germany

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: 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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment

Primary outcome: Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 1 day of treatment

Secondary outcome:

Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 2 to 7 days of treatment

Symptom relief rates as measured by ReQuest™ after 7 days of treatment

Safety

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Nycomed Deutschland GmbH, Marburg 35043, Germany

Nycomed Deutschland GmbH, Rostock 18057, Germany

Nycomed Deutschland GmbH, Berlin 10117, Germany

Nycomed Deutschland GmbH, München 81377, Germany

Nycomed Deutschland GmbH, Leipzig 04103, Germany

Nycomed Deutschland GmbH, Kassel 34125, Germany

Nycomed Deutschland GmbH, Recklinghausen 45655, Germany

Nycomed Deutschland GmbH, Wiesbaden 65189, Germany

Nycomed Deutschland GmbH, Jena 07747, Germany

Nycomed Deutschland GmbH, Offenbach 63069, Germany

Nycomed Deutschland GmbH, Augsburg 86156, Germany

Nycomed Deutschland GmbH, Hamburg 21075, Germany

Nycomed Deutschland GmbH, Greifswald 17489, Germany

Nycomed Deutschland GmbH, Ludwigshafen 67063, Germany

Nycomed Deutschland GmbH, Halle (Saale) 06110, Germany

Nycomed Deutschland GmbH, Göttingen 37075, Germany

Nycomed Deutschland GmbH, Köln 51109, Germany

Nycomed Deutschland GmbH, Gera 07548, Germany

Nycomed Deutschland GmbH, Frankfurt 60569, Germany

Nycomed Deutschland GmbH, Münster 48149, Germany

Nycomed Deutschland GmbH, Neubrandenburg 17036, Germany

Nycomed Deutschland GmbH, Brandenburg 14770, Germany

Nycomed Deutschland GmbH, Stade 21682, Germany

Nycomed Deutschland GmbH, Ludwigsburg 71640, Germany

Nycomed Deutschland GmbH, Frankfurt 60488, Germany

Nycomed Deutschland GmbH, Köln 51067, Germany

Nycomed Deutschland GmbH, Minden 32427, Germany

Nycomed Deutschland GmbH, Hamburg 22457, Germany

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Nycomed Deutschland GmbH, Kiel 24105, Germany

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Nycomed Deutschland GmbH, Mainz 55131, Germany

Nycomed Deutschland GmbH, Ingolstadt 85049, Germany

Nycomed Deutschland GmbH, Erlangen 91054, Germany

Starting date: October 2006
Ending date: November 2007
Last updated: March 20, 2008