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”

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.

Study Type: Interventional

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

Study Primary Completion Date: July 2007

Intervention(s) in this Clinical Trial

• Drug: Pantoprazole
  • Efficacy of Pantoprazole

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Pantoprazole 20 mg
• Active Comparator: 2
  • Pantoprazole 40 mg

Primary Measures

• Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 1 day of treatment
  • Time Frame: 1 day
    Safety Issue?: No

Secondary Measures

• Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 2 to 7 days of treatment
  • Time Frame: 7 days
    Safety Issue?: No
• Symptom relief rates as measured by ReQuest™ after 7 days of treatment
  • Time Frame: 7 days
    Safety Issue?: No
• Safety
  • Time Frame: 7 days
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Nycomed

Overall Clinical Trial Officials and Contacts

Joachim Mössner, Prof. Principal Investigator Universitätsklinikum Leipzig, Leipzig, Germany  

Information obtained from ClinicalTrials.gov on October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00326027

Study ID Number: BY1023/DE-004

ClinicalTrials.gov Identifier: NCT00326027

Health Authority: Germany: Federal Institute for Drugs and Medical Devices