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

Gastroesophageal Reflux Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00326027
• Other study ID #: BY1023/DE-004
• Status: Completed
• Phase: Phase 3
• First received: May 15, 2006
• Last updated: May 4, 2012
• Start date: October 2006
• Est. completion date: November 2007

Study information

• Verified date: May 2012
• Source: Nycomed
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: November 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Drug:
• Pantoprazole
Efficacy of Pantoprazole

Locations

Country	Name	City	State
Germany	Nycomed Deutschland GmbH	Augsburg
Germany	Nycomed Deutschland GmbH	Berlin
Germany	Nycomed Deutschland GmbH	Brandenburg
Germany	Nycomed Deutschland GmbH	Erlangen
Germany	Nycomed Deutschland GmbH	Frankfurt
Germany	Nycomed Deutschland GmbH	Frankfurt
Germany	Nycomed Deutschland GmbH	Gera
Germany	Nycomed Deutschland GmbH	Göttingen
Germany	Nycomed Deutschland GmbH	Greifswald
Germany	Nycomed Deutschland GmbH	Halle (Saale)
Germany	Nycomed Deutschland GmbH	Hamburg
Germany	Nycomed Deutschland GmbH	Hamburg
Germany	Nycomed Deutschland GmbH	Ingolstadt
Germany	Nycomed Deutschland GmbH	Jena
Germany	Nycomed Deutschland GmbH	Kassel
Germany	Nycomed Deutschland GmbH	Kiel
Germany	Nycomed Deutschland GmbH	Köln
Germany	Nycomed Deutschland GmbH	Köln
Germany	Nycomed Deutschland GmbH	Leipzig
Germany	Nycomed Deutschland GmbH	Lübeck
Germany	Nycomed Deutschland GmbH	Ludwigsburg
Germany	Nycomed Deutschland GmbH	Ludwigshafen
Germany	Nycomed Deutschland GmbH	Mainz
Germany	Nycomed Deutschland GmbH	Marburg
Germany	Nycomed Deutschland GmbH	Minden
Germany	Nycomed Deutschland GmbH	München
Germany	Nycomed Deutschland GmbH	Münster
Germany	Nycomed Deutschland GmbH	Neubrandenburg
Germany	Nycomed Deutschland GmbH	Offenbach
Germany	Nycomed Deutschland GmbH	Oldenburg
Germany	Nycomed Deutschland GmbH	Recklinghausen
Germany	Nycomed Deutschland GmbH	Rostock
Germany	Nycomed Deutschland GmbH	Stade
Germany	Nycomed Deutschland GmbH	Weimar
Germany	Nycomed Deutschland GmbH	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
Nycomed

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 1 day of treatment		1 day	No
Secondary	Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 2 to 7 days of treatment		7 days	No
Secondary	Symptom relief rates as measured by ReQuest™ after 7 days of treatment		7 days	No
Secondary	Safety		7 days	Yes