Status:
COMPLETED
Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Non-erosive Reflux or Gastroesophageal Reflux Disease (BY1023/DE-004)
Lead Sponsor:
Nycomed
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 A...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00326027
Start Date
October 1 2006
End Date
November 1 2007
Last Update
May 7 2012
Active Locations (35)
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1
Nycomed Deutschland GmbH
Augsburg, Germany, 86156
2
Nycomed Deutschland GmbH
Berlin, Germany, 10117
3
Nycomed Deutschland GmbH
Brandenburg, Germany, 14770
4
Nycomed Deutschland GmbH
Cologne, Germany, 51067