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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)

This study has been completed.
Sponsor:
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT00326027
First received: May 15, 2006
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Gastroesophageal Reflux
Drug: Pantoprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Nycomed:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]
  • Symptom relief rates as measured by ReQuest™ after 7 days of treatment [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Enrollment: 29
Study Start Date: October 2006
Study Completion Date: November 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Pantoprazole 20 mg
Drug: Pantoprazole
Efficacy of Pantoprazole
Active Comparator: 2
Pantoprazole 40 mg
Drug: Pantoprazole
Efficacy of Pantoprazole

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326027

Locations
Germany
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, 60569
Nycomed Deutschland GmbH
Frankfurt, Germany, 60488
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, 22457
Nycomed Deutschland GmbH
Hamburg, Germany, 21075
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, 51109
Nycomed Deutschland GmbH
Köln, Germany, 51067
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
Nycomed
Investigators
Principal Investigator: Joachim Mössner, Prof. Universitätsklinikum Leipzig, Leipzig, Germany
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00326027     History of Changes
Other Study ID Numbers: BY1023/DE-004
Study First Received: May 15, 2006
Last Updated: May 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Nycomed:
GERD
Pantoprazole
NERD

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

ClinicalTrials.gov processed this record on November 25, 2014