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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-000493-32-SK
Enrollment
1980
Registered
2004-07-06
Start date
2004-08-17
Completion date
Unknown
Last updated
2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal reflux esophagitis MedDRA version: 5.0 Level: llt Classification code 10038263

Interventions

Product Name: Pantoprazole-Magnesium Product Code: BY1023 Pharmaceutical Form: Capsule* Current Sponsor code: BY1023 Other descriptive name: Pantoprazol-Magnesium dihydrate Concentration unit: mg mill

Sponsors

ALTANA Pharma AG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 A-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

Exclusion criteria: Gastrointestinal diseases: - 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

Design outcomes

Primary

MeasureTime frame
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 A-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. - Endoscopically confirmed healing depending on initial grade of gastroesophageal reflux esophagitis. - Endoscopically confirmed healing depending on H. pylori status. - Gastrointestinal complaints (as documented in the CRF by the investigator) - Response to treatment on the basis of the ReQuest total score, the subscale ;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—

Countries

Austria, Czech Republic, Slovakia

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026