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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.

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

MedlinePlus related topics:   GERD   

ChemIDplus related topics:   Pantoprazole    Pantoprazole Sodium   

U.S. FDA Resources

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

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  Show 45 Study Locations

Sponsors and Collaborators
ALTANA Pharma

Investigators
Principal Investigator:     Werner Janssen, MD     23569 Lübeck, Germany    
  More Information


Study ID Numbers:   BY1023/M3-342
First Received:   May 12, 2006
Last Updated:   July 16, 2008
ClinicalTrials.gov Identifier:   NCT00325676
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:
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008




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