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CompletedNCT00326027Updated May 7, 2012

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

A Phase 3 interventional study of Pantoprazole in Gastroesophageal Reflux, sponsored by Nycomed. Completed at 35 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-07.

Sponsored by Nycomed · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
29
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Gastroesophageal Reflux

Keywords

  • GERD
  • Pantoprazole
  • NERD
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 29 is below the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Nycomed is the lead sponsor of 31 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Active comparator
    1

    Pantoprazole 20 mg

    Drug: Pantoprazole

  • Active comparator
    2

    Pantoprazole 40 mg

    Drug: Pantoprazole

Interventions

  • DrugPantoprazole

    Efficacy of Pantoprazole

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

35 sites
  • Nycomed Deutschland GmbH
    Augsburg, 86156, Germany
  • Nycomed Deutschland GmbH
    Berlin, 10117, Germany
  • Nycomed Deutschland GmbH
    Brandenburg, 14770, 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
    Greifswald, 17489, Germany
  • Nycomed Deutschland GmbH
    Göttingen, 37075, Germany
  • Nycomed Deutschland GmbH
    Halle (Saale), 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
    Köln, 51067, Germany
  • Nycomed Deutschland GmbH
    Köln, 51109, 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00326027
Lead sponsor
Nycomed
First posted
May 16, 2006
Start date
Oct 2006
Primary completion
Jul 2007
Completion
Nov 2007
Last update
May 7, 2012

Study contacts

Joachim Mössner, Prof.
principal investigator · Universitätsklinikum Leipzig, Leipzig, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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