Comparison of the Classical Healing Concept With the Complete Remission Concept After Treatment With Pantoprazole in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) (BY1023/M3-342)

Condition(s) targeted: Gastroesophageal Reflux Disease

Intervention: Pantoprazole (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: ALTANA Pharma

Official(s) and/or principal investigator(s):
Werner Janssen, MD, Principal Investigator, Affiliation: 23569 Lübeck, Germany

The aim of this study is to evaluate the complete remission rates, endoscopic relapses, study discontinuation rates, and quality of life parameters in patients with erosive GERD. The study duration consists of a treatment period up to 16 weeks according to the classical healing concept or the complete remission concept. During this period, the patients will receive pantoprazole (tablet) at one dose level once daily. The following observational phase lasts up to 6 months. The study will provide further data on efficacy, safety, and tolerability of pantoprazole.

Official title: CONFIRM – Confirmation of Superiority of Complete Remission Concept Versus Classical Healing Concept for Treatment of Patients With Erosive GERD

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Primary outcome: time to endoscopic relapse and/or unwillingness to continue due to GERD related symptoms

Secondary outcome:

further efficacy criteria

safety

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Main Inclusion Criteria:

- Written informed consent

- Endoscopically confirmed GERD (Los Angeles classification A-D)

- Patients whose compliance is expected to be high with respect to the completion of the

questionnaires

Main Exclusion Criteria:

- Other gastrointestinal diseases

- Severe concomitant diseases

- Proton pump inhibitors (PPIs) during last 14 days before start

- H2 receptor antagonists, prokinetics during last 7 days before study start

- Helicobacter pylori (H. pylori) eradication during last 28 days before study start

ALTANA Pharma, Cities in Germany, Germany

ALTANA Pharma, Cities in Poland, Poland

ALTANA Pharma, Cities in South Africa, South Africa

Starting date: June 2006
Last updated: June 11, 2007