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)

This study has been completed.

First Received: May 12, 2006 Last Updated: July 16, 2008 History of Changes

Sponsored by:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00325676

Purpose

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.

Condition	Intervention	Phase
Gastroesophageal Reflux Disease	Drug: Pantoprazole	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	CONFIRM - Confirmation of Superiority of Complete Remission Concept Versus Classical Healing Concept for Treatment of Patients With Erosive GERD

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: Pantoprazole Pantoprazole Sodium

U.S. FDA Resources

Further study details as provided by ALTANA Pharma:

Primary Outcome Measures:

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

Secondary Outcome Measures:

further efficacy criteria
safety

Enrollment:	639
Study Start Date:	June 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325676

Show 45 Study Locations

Sponsors and Collaborators

ALTANA Pharma

Investigators

Principal Investigator:

Werner Janssen, MD

23569 Lübeck, Germany

More Information

No publications provided

Study ID Numbers:	BY1023/M3-342
Study First Received:	May 12, 2006
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00325676 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by ALTANA Pharma:

GERD
Pantoprazole
Complete Remission

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal Disorder

Gastrointestinal Diseases
Pantoprazole
Esophageal Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Gastrointestinal Diseases
Therapeutic Uses
Pantoprazole

Anti-Ulcer Agents
Gastrointestinal Agents
Esophageal Diseases
Gastroesophageal Reflux
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 01, 2009