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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00326027
Recruitment Status : Completed
First Posted : May 16, 2006
Last Update Posted : May 7, 2012
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Drug: Pantoprazole Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2006
Primary Completion Date : July 2007
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Pantoprazole 20 mg
Drug: Pantoprazole
Efficacy of Pantoprazole
Active Comparator: 2
Pantoprazole 40 mg
Drug: Pantoprazole
Efficacy of Pantoprazole

Primary Outcome Measures :
  1. Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 1 day of treatment [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. 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 ]
  2. Symptom relief rates as measured by ReQuest™ after 7 days of treatment [ Time Frame: 7 days ]
  3. Safety [ Time Frame: 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00326027

Nycomed Deutschland GmbH
Augsburg, Germany, 86156
Nycomed Deutschland GmbH
Berlin, Germany, 10117
Nycomed Deutschland GmbH
Brandenburg, Germany, 14770
Nycomed Deutschland GmbH
Erlangen, Germany, 91054
Nycomed Deutschland GmbH
Frankfurt, Germany, 60488
Nycomed Deutschland GmbH
Frankfurt, Germany, 60569
Nycomed Deutschland GmbH
Gera, Germany, 07548
Nycomed Deutschland GmbH
Greifswald, Germany, 17489
Nycomed Deutschland GmbH
Göttingen, Germany, 37075
Nycomed Deutschland GmbH
Halle (Saale), Germany, 06110
Nycomed Deutschland GmbH
Hamburg, Germany, 21075
Nycomed Deutschland GmbH
Hamburg, Germany, 22457
Nycomed Deutschland GmbH
Ingolstadt, Germany, 85049
Nycomed Deutschland GmbH
Jena, Germany, 07747
Nycomed Deutschland GmbH
Kassel, Germany, 34125
Nycomed Deutschland GmbH
Kiel, Germany, 24105
Nycomed Deutschland GmbH
Köln, Germany, 51067
Nycomed Deutschland GmbH
Köln, Germany, 51109
Nycomed Deutschland GmbH
Leipzig, Germany, 04103
Nycomed Deutschland GmbH
Ludwigsburg, Germany, 71640
Nycomed Deutschland GmbH
Ludwigshafen, Germany, 67063
Nycomed Deutschland GmbH
Lübeck, Germany, 23538
Nycomed Deutschland GmbH
Mainz, Germany, 55131
Nycomed Deutschland GmbH
Marburg, Germany, 35043
Nycomed Deutschland GmbH
Minden, Germany, 32427
Nycomed Deutschland GmbH
München, Germany, 81377
Nycomed Deutschland GmbH
Münster, Germany, 48149
Nycomed Deutschland GmbH
Neubrandenburg, Germany, 17036
Nycomed Deutschland GmbH
Offenbach, Germany, 63069
Nycomed Deutschland GmbH
Oldenburg, Germany, 26133
Nycomed Deutschland GmbH
Recklinghausen, Germany, 45655
Nycomed Deutschland GmbH
Rostock, Germany, 18057
Nycomed Deutschland GmbH
Stade, Germany, 21682
Nycomed Deutschland GmbH
Weimar, Germany, 99425
Nycomed Deutschland GmbH
Wiesbaden, Germany, 65189
Sponsors and Collaborators
Principal Investigator: Joachim Mössner, Prof. Universitätsklinikum Leipzig, Leipzig, Germany Identifier: NCT00326027     History of Changes
Other Study ID Numbers: BY1023/DE-004
First Posted: May 16, 2006    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: May 2012

Keywords provided by Nycomed:

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action