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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)

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ClinicalTrials.gov Identifier: NCT00325676
Recruitment Status : Completed
First Posted : May 15, 2006
Last Update Posted : May 7, 2012
Sponsor:
Information provided by:
Takeda

Brief Summary:
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 or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Drug: Pantoprazole Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 639 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CONFIRM - Confirmation of Superiority of Complete Remission Concept Versus Classical Healing Concept for Treatment of Patients With Erosive GERD
Study Start Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources




Primary Outcome Measures :
  1. time to endoscopic relapse and/or unwillingness to continue due to GERD related symptoms

Secondary Outcome Measures :
  1. further efficacy criteria
  2. safety


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325676


  Show 45 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Principal Investigator: Werner Janssen, MD 23569 Lübeck, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00325676     History of Changes
Other Study ID Numbers: BY1023/M3-342
First Posted: May 15, 2006    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: June 2007

Keywords provided by Takeda:
GERD
Pantoprazole
Complete Remission

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action