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

Phase 3

Completed

• Conditions: Gastroesophageal Reflux
• Interventions: Drug: Pantoprazole

• Registration Number: NCT00326027
• Lead Sponsor: Nycomed

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-05-15
• Study First Submitted QC: 2006-05-15
• Study First Posted: 2006-05-16
• Study Start: 2006-10
• Primary Completion: 2007-07
• Study Completion: 2007-11
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Pantoprazole	Pantoprazole 20 mg
2	Pantoprazole	Pantoprazole 40 mg

Primary Outcome Measures

Name	Time	Method
Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 1 day of treatment	1 day

Secondary Outcome Measures

Name	Time	Method
Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 2 to 7 days of treatment	7 days
Symptom relief rates as measured by ReQuest™ after 7 days of treatment	7 days
Safety	7 days

Trial Locations

Locations (1)

Nycomed Deutschland GmbH; 🇩🇪 Wiesbaden, Germany