Clinical trial NCT00326027: Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Non-erosive Reflux or Gastroesophageal Reflux Disease (BY1023/DE-004)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux
Keywords: GERD
Pantoprazole
NERD
Lead sponsor: Nycomed
Sponsor class: INDUSTRY
First posted: 2006-05-16
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 1 day of treatment
timeFrame: 1 day
Secondary outcomes:
measure: Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 2 to 7 days of treatment
timeFrame: 7 days
measure: Symptom relief rates as measured by ReQuest™ after 7 days of treatment
timeFrame: 7 days
measure: Safety
timeFrame: 7 days
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Berlin
country: Germany
facility: Nycomed Deutschland GmbH
city: Brandenburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Erlangen
country: Germany
facility: Nycomed Deutschland GmbH
city: Frankfurt
country: Germany
facility: Nycomed Deutschland GmbH
city: Frankfurt
country: Germany
facility: Nycomed Deutschland GmbH
city: Gera
country: Germany
facility: Nycomed Deutschland GmbH
city: Greifswald
country: Germany
facility: Nycomed Deutschland GmbH
city: Göttingen
country: Germany
facility: Nycomed Deutschland GmbH
city: Halle (Saale)
country: Germany
facility: Nycomed Deutschland GmbH
city: Hamburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Hamburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Ingolstadt
country: Germany
facility: Nycomed Deutschland GmbH
city: Jena
country: Germany
facility: Nycomed Deutschland GmbH
city: Kassel
country: Germany
facility: Nycomed Deutschland GmbH
city: Kiel
country: Germany
facility: Nycomed Deutschland GmbH
city: Köln
country: Germany
facility: Nycomed Deutschland GmbH
city: Köln
country: Germany
facility: Nycomed Deutschland GmbH
city: Leipzig
country: Germany
facility: Nycomed Deutschland GmbH
city: Ludwigsburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Ludwigshafen
country: Germany
facility: Nycomed Deutschland GmbH
city: Lübeck
country: Germany
facility: Nycomed Deutschland GmbH
city: Mainz
country: Germany
facility: Nycomed Deutschland GmbH
city: Marburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Minden
country: Germany
facility: Nycomed Deutschland GmbH
city: München
country: Germany
facility: Nycomed Deutschland GmbH
city: Münster
country: Germany
facility: Nycomed Deutschland GmbH
city: Neubrandenburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Offenbach
country: Germany
facility: Nycomed Deutschland GmbH
city: Oldenburg
country: Germany
facility: Nycomed Deutschland GmbH
city: Recklinghausen
country: Germany
facility: Nycomed Deutschland GmbH
city: Rostock
country: Germany
facility: Nycomed Deutschland GmbH
city: Stade
country: Germany
facility: Nycomed Deutschland GmbH
city: Weimar
country: Germany
facility: Nycomed Deutschland GmbH
city: Wiesbaden
country: Germany
facility: Nycomed Deutschland GmbH
Study officials:
affiliation: Universitätsklinikum Leipzig, Leipzig, Germany
name: Joachim Mössner, Prof.
role: PRINCIPAL_INVESTIGATOR
References: