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

Last updated: May 4, 2012
Sponsor: Nycomed
Overall Status: Completed

Phase

3

Condition

Gastroesophageal Reflux Disease (Gerd)

Heartburn (Pediatric)

Esophageal Disorders

Treatment

N/A

Clinical Study ID

NCT00326027
BY1023/DE-004
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 sinceadmission to the hospital) non-erosive reflux disease (NERD) or erosivegastroesophageal reflux disease (GERD, LA Grade A-D)

Exclusion

Main Exclusion Criteria:

  • Known Zollinger-Ellison syndrome or other gastric hypersecretory condition

  • Previous acid-lowering surgery or other surgery of the esophagus and/or uppergastrointestinal 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 withknown high-grade dysplasia or longer than 3 cm

  • Acute peptic ulcer and/or ulcer complications

  • Pyloric stenosis

  • Known inflammatory bowel diseases

Study Design

Total Participants: 29
Study Start date:
October 01, 2006
Estimated Completion Date:
November 30, 2007

Connect with a study center

  • Nycomed Deutschland GmbH

    Augsburg, 86156
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Berlin, 10117
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Brandenburg, 14770
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Erlangen, 91054
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Frankfurt, 60488
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Gera, 07548
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Greifswald, 17489
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Göttingen, 37075
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Göttingen, 37075
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Halle (Saale), 06110
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Hamburg, 22457
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Ingolstadt, 85049
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Jena, 07747
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Kassel, 34125
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Kiel, 24105
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Köln, 51067
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Köln, 51067
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Leipzig, 04103
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Ludwigsburg, 71640
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Ludwigshafen, 67063
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Lübeck, 23538
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Lübeck, 23538
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Mainz, 55131
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Marburg, 35043
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Minden, 32427
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    München, 81377
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Münster, 48149
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    München, 81377
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Münster, 48149
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Neubrandenburg, 17036
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Offenbach, 63069
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Oldenburg, 26133
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Recklinghausen, 45655
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Rostock, 18057
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Stade, 21682
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Weimar, 99425
    Germany

    Site Not Available

  • Nycomed Deutschland GmbH

    Wiesbaden, 65189
    Germany

    Site Not Available

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