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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastroesophageal Reflux

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Pantoprazole 20 mg

Group Type ACTIVE_COMPARATOR

Pantoprazole

Intervention Type DRUG

Efficacy of Pantoprazole

2

Pantoprazole 40 mg

Group Type ACTIVE_COMPARATOR

Pantoprazole

Intervention Type DRUG

Efficacy of Pantoprazole

Interventions

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Pantoprazole

Efficacy of Pantoprazole

Intervention Type DRUG

Eligibility Criteria

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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)

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No