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)

May 4, 2012 updated by: Takeda

CONFIRM - Confirmation of Superiority of Complete Remission Concept Versus Classical Healing Concept for Treatment of Patients With Erosive GERD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

639

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Belo Horizonte-MG, Brazil, 30150270
        • Altana Pharma/Nycomed
      • Blumenau - SC, Brazil, 89010906
        • Altana Pharma/Nycomed
      • Botucatu - SP, Brazil, 18610970
        • Altana Pharma/Nycomed
      • Campinas - SP, Brazil, 13013101
        • Altana Pharma/Nycomed
      • Campinas - Sao Paulo, Brazil, 13070040
        • Altana Pharma/Nycomed
      • Curitiba - PR, Brazil, 80060
        • Altana Pharma/Nycomed
      • Ilha do Fundao - Rio de Janeiro - RJ, Brazil, 21941590
        • Altana Pharma/Nycomed
      • Pinheiros Sao Paulo - SP, Brazil, 1246-000
        • Altana Pharma/Nycomed
      • Porto Alegre - RS, Brazil, 90035003
        • Altana Pharma/Nycomed
      • Porto Alegre-RS, Brazil, 90020090
        • Altana Pharma/Nycomed
      • Porto Alegre-RS, Brazil, 90610000
        • Altana Pharma/Nycomed
      • Ribeirao Preto-SP, Brazil, 14048900
        • Altana Pharma/Nycomed
      • Salvador-BA, Brazil, 41256900
        • Altana Pharma/Nycomed
      • Sao Paulo, Brazil, 4024002
        • Altana Pharma/Nycomed
  • Germany
      • Bad Schwalbach, Germany, 65307
        • Altana Pharma/Nycomed
      • Burg, Germany, 39288
        • Altana Pharma/Nycomed
      • Gardelegen, Germany, 39638
        • Altana Pharma/Nycomed
      • Königstein, Germany, 61462
        • Altana Pharma/Nycomed
      • Lübeck, Germany, 23569
        • Altana Pharma/Nycomed
      • Lüdenscheid, Germany, 58507
        • Altana Pharma/Nycomed
      • Lütjenburg, Germany, 24321
        • Altana Pharma/Nycomed
      • Nieder-Olm, Germany, 55268
        • Altana Pharma/Nycomed
      • Oelde, Germany, 59302
        • Altana Pharma/Nycomed
      • Wiesbaden, Germany, 65189
        • Altana Pharma/Nycomed
      • Wolmirstedt, Germany, 39326
        • Altana Pharma/Nycomed
  • Poland
      • Bydgoszcz, Poland, 85-681
        • Altana Pharma/Nycomed
      • Inowroclaw, Poland, 88-100
        • Altana Pharma/Nycomed
      • Poznan, Poland, 60479
        • Altana Pharma/Nycomed
      • Siemianowice Slaskie, Poland, 41-100
        • Altana Pharma/Nycomed
      • Torun, Poland, 87-100
        • Altana Pharma/Nycomed
      • Tychy, Poland, 43-100
        • Altana Pharma/Nycomed
  • South Africa
      • Amanzimtoti, South Africa, 4126
        • Altana Pharma/Nycomed
      • Berea, Durban, South Africa, 4000
        • Altana Pharma/Nycomed
      • Bloemfontein, South Africa, 9317
        • Altana Pharma/Nycomed
      • Bloemfontein, South Africa, 9301
        • Altana Pharma/Nycomed
      • Cape Town, South Africa, 7530
        • Altana Pharma/Nycomed
      • Durban, South Africa, 4001
        • Altana Pharma/Nycomed
      • Goodwood, South Africa, 7460
        • Altana Pharma/Nycomed
      • Johannesburg, South Africa, 2033
        • Altana Pharma/Nycomed
      • Overport, Durban, South Africa, 4001
        • Altana Pharma/Nycomed
      • Panorama, South Africa, 7500
        • Altana Pharma/Nycomed
      • Pinetown, South Africa, 4013
        • Altana Pharma/Nycomed
      • Port Elizabeth, South Africa, 6001
        • Altana Pharma/Nycomed
      • Pretoria, South Africa, 48
        • Altana Pharma/Nycomed
      • Somerset-West, South Africa, 7130
        • Altana Pharma/Nycomed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
safety
further efficacy criteria

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Principal Investigator: Werner Janssen, MD, 23569 Lübeck, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Registration Dates

First Submitted

May 12, 2006

First Submitted That Met QC Criteria

May 12, 2006

First Posted (Estimate)

May 15, 2006

Study Record Updates

Last Update Posted (Estimate)

May 7, 2012

Last Update Submitted That Met QC Criteria

May 4, 2012

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BY1023/M3-342

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastroesophageal Reflux Disease

Clinical Trials on Pantoprazole

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe