Healing of patients suffering from gastroesophageal reflux esophagitisgrade C-D according to Los Angeles classification after treatment with pantoprazole-magnesium dihydrate 80 mg o.d. in comparison topantoprazole-sodium sesquihydrate 40 mg o.d. over 4 or 8 weeks

• Conditions: Gastroesophageal reflux esophagitis; MedDRA version: 5.0Level: lltClassification code 10038263

• Registration Number: EUCTR2004-000492-33-LV
• Lead Sponsor: ALTANA Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

- Written informed consent by the patient for study participation, prior to protocol specific procedures
- Outpatients of at least 18 years of age
- Endoscopically confirmed gastroesophageal reflux esophagitis (LA grade C-D)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Gastrointestinal diseases:
- Endoscopically confirmed gastroesophageal reflux esophagitis (LA grade A-B)
- 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
- Symptomatic GERD without any endoscopic findings
- Acute peptic ulcer and/or ulcer complications
- Pyloric stenosis
- Inflammatory bowel diseases

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the superiority in healing rates of pantoprazole-Mg 80 mg o.d. versus pantoprazole-Na 40 mg o.d. in patients with gastroesophageal reflux esophagitis (LA grade C-D) after 4 weeks of treatment.;Secondary Objective: - Endoscopically confirmed healing of gastroesophageal reflux esophagitis after 8 weeks of treatment with either pantoprazole-Mg or pantoprazole-Na.<br>- Endoscopically confirmed healing depending on initial grade of gastroesophageal reflux esophagitis.<br>- Endoscopically confirmed healing depending on H. pylori status.<br>- Gastrointestinal complaints (as documented in the CRF by the investigator)<br>- Response to treatment on the basis of the ReQuest total score, the subscale ReQuest-GI and the subscale ReQuest-WSO;Primary end point(s): Endoscopically confirmed healing of gastroesophageal reflux esophagitis after 4 weeks of treatment with either pantoprazole-Mg 80 mg or pantoprazole-Na 40 mg