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.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00325676
First received: May 12, 2006
Last updated: May 4, 2012
Last verified: June 2007
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Takeda:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided by Takeda

Additional 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
Study First Received: May 12, 2006
Last Updated: May 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014