Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Non-erosive Reflux or Gastroesophageal Reflux Disease (BY1023/DE-004)
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
1 other identifier
interventional
29
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2006
Shorter than P25 for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2006
CompletedFirst Posted
Study publicly available on registry
May 16, 2006
CompletedStudy Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedMay 7, 2012
May 1, 2012
9 months
May 15, 2006
May 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 1 day of treatment
1 day
Secondary Outcomes (3)
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
Study Arms (2)
1
ACTIVE COMPARATORPantoprazole 20 mg
2
ACTIVE COMPARATORPantoprazole 40 mg
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nycomedlead
Study Sites (35)
Nycomed Deutschland GmbH
Augsburg, 86156, Germany
Nycomed Deutschland GmbH
Berlin, 10117, Germany
Nycomed Deutschland GmbH
Brandenburg, 14770, Germany
Nycomed Deutschland GmbH
Cologne, 51067, Germany
Nycomed Deutschland GmbH
Cologne, 51109, Germany
Nycomed Deutschland GmbH
Erlangen, 91054, Germany
Nycomed Deutschland GmbH
Frankfurt, 60488, Germany
Nycomed Deutschland GmbH
Frankfurt, 60569, Germany
Nycomed Deutschland GmbH
Gera, 07548, Germany
Nycomed Deutschland GmbH
Göttingen, 37075, Germany
Nycomed Deutschland GmbH
Greifswald, 17489, Germany
Nycomed Deutschland GmbH
Halle, 06110, Germany
Nycomed Deutschland GmbH
Hamburg, 21075, Germany
Nycomed Deutschland GmbH
Hamburg, 22457, Germany
Nycomed Deutschland GmbH
Ingolstadt, 85049, Germany
Nycomed Deutschland GmbH
Jena, 07747, Germany
Nycomed Deutschland GmbH
Kassel, 34125, Germany
Nycomed Deutschland GmbH
Kiel, 24105, Germany
Nycomed Deutschland GmbH
Leipzig, 04103, Germany
Nycomed Deutschland GmbH
Ludwigsburg, 71640, Germany
Nycomed Deutschland GmbH
Ludwigshafen, 67063, Germany
Nycomed Deutschland GmbH
Lübeck, 23538, Germany
Nycomed Deutschland GmbH
Mainz, 55131, Germany
Nycomed Deutschland GmbH
Marburg, 35043, Germany
Nycomed Deutschland GmbH
Minden, 32427, Germany
Nycomed Deutschland GmbH
München, 81377, Germany
Nycomed Deutschland GmbH
Münster, 48149, Germany
Nycomed Deutschland GmbH
Neubrandenburg, 17036, Germany
Nycomed Deutschland GmbH
Offenbach, 63069, Germany
Nycomed Deutschland GmbH
Oldenburg, 26133, Germany
Nycomed Deutschland GmbH
Recklinghausen, 45655, Germany
Nycomed Deutschland GmbH
Rostock, 18057, Germany
Nycomed Deutschland GmbH
Stade, 21682, Germany
Nycomed Deutschland GmbH
Weimar, 99425, Germany
Nycomed Deutschland GmbH
Wiesbaden, 65189, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joachim Mössner, Prof.
Universitätsklinikum Leipzig, Leipzig, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 15, 2006
First Posted
May 16, 2006
Study Start
October 1, 2006
Primary Completion
July 1, 2007
Study Completion
November 1, 2007
Last Updated
May 7, 2012
Record last verified: 2012-05