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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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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




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

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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


Locations
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Brazil
Altana Pharma/Nycomed
Belo Horizonte-MG, Brazil, 30150270
Altana Pharma/Nycomed
Blumenau - SC, Brazil, 89010906
Altana Pharma/Nycomed
Botucatu - SP, Brazil, 18610970
Altana Pharma/Nycomed
Campinas - Sao Paulo, Brazil, 13070040
Altana Pharma/Nycomed
Campinas - SP, Brazil, 13013101
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
Germany
Altana Pharma/Nycomed
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
Poland
Altana Pharma/Nycomed
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
South Africa
Altana Pharma/Nycomed
Amanzimtoti, South Africa, 4126
Altana Pharma/Nycomed
Berea, Durban, South Africa, 4000
Altana Pharma/Nycomed
Bloemfontein, South Africa, 9301
Altana Pharma/Nycomed
Bloemfontein, South Africa, 9317
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
Sponsors and Collaborators
Takeda
Investigators
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Principal Investigator: Werner Janssen, MD 23569 Lübeck, Germany
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00325676    
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:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action