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)
CONFIRM - Confirmation of Superiority of Complete Remission Concept Versus Classical Healing Concept for Treatment of Patients With Erosive GERD
1 other identifier
interventional
639
4 countries
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2006
CompletedFirst Posted
Study publicly available on registry
May 15, 2006
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedMay 7, 2012
June 1, 2007
May 12, 2006
May 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time to endoscopic relapse and/or unwillingness to continue due to GERD related symptoms
Secondary Outcomes (2)
further efficacy criteria
safety
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (45)
Altana Pharma/Nycomed
Belo Horizonte-MG, 30150270, Brazil
Altana Pharma/Nycomed
Blumenau - SC, 89010906, Brazil
Altana Pharma/Nycomed
Botucatu - SP, 18610970, Brazil
Altana Pharma/Nycomed
Campinas - Sao Paulo, 13070040, Brazil
Altana Pharma/Nycomed
Campinas - SP, 13013101, Brazil
Altana Pharma/Nycomed
Curitiba - PR, 80060, Brazil
Altana Pharma/Nycomed
Ilha Do Fundao - Rio de Janeiro - RJ, 21941590, Brazil
Altana Pharma/Nycomed
Pinheiros Sao Paulo - SP, 1246-000, Brazil
Altana Pharma/Nycomed
Porto Alegre - RS, 90035003, Brazil
Altana Pharma/Nycomed
Porto Alegre-RS, 90020090, Brazil
Altana Pharma/Nycomed
Porto Alegre-RS, 90610000, Brazil
Altana Pharma/Nycomed
Ribeirao Preto-SP, 14048900, Brazil
Altana Pharma/Nycomed
Salvador-BA, 41256900, Brazil
Altana Pharma/Nycomed
São Paulo, 4024002, Brazil
Altana Pharma/Nycomed
Bad Schwalbach, 65307, Germany
Altana Pharma/Nycomed
Burg, 39288, Germany
Altana Pharma/Nycomed
Gardelegen, 39638, Germany
Altana Pharma/Nycomed
Königstein, 61462, Germany
Altana Pharma/Nycomed
Lübeck, 23569, Germany
Altana Pharma/Nycomed
Lüdenscheid, 58507, Germany
Altana Pharma/Nycomed
Lütjenburg, 24321, Germany
Altana Pharma/Nycomed
Nieder-Olm, 55268, Germany
Altana Pharma/Nycomed
Oelde, 59302, Germany
Altana Pharma/Nycomed
Wiesbaden, 65189, Germany
Altana Pharma/Nycomed
Wolmirstedt, 39326, Germany
Altana Pharma/Nycomed
Bydgoszcz, 85-681, Poland
Altana Pharma/Nycomed
Inowrocław, 88-100, Poland
Altana Pharma/Nycomed
Poznan, 60479, Poland
Altana Pharma/Nycomed
Siemianowice Śląskie, 41-100, Poland
Altana Pharma/Nycomed
Torun, 87-100, Poland
Altana Pharma/Nycomed
Tychy, 43-100, Poland
Altana Pharma/Nycomed
Berea, Durban, 4000, South Africa
Altana Pharma/Nycomed
Bloemfontein, 9301, South Africa
Altana Pharma/Nycomed
Bloemfontein, 9317, South Africa
Altana Pharma/Nycomed
Cape Town, 7530, South Africa
Altana Pharma/Nycomed
Durban, 4001, South Africa
Altana Pharma/Nycomed
eManzimtoti, 4126, South Africa
Altana Pharma/Nycomed
Goodwood, 7460, South Africa
Altana Pharma/Nycomed
Johannesburg, 2033, South Africa
Altana Pharma/Nycomed
Overport, Durban, 4001, South Africa
Altana Pharma/Nycomed
Panorama, 7500, South Africa
Altana Pharma/Nycomed
Pinetown, 4013, South Africa
Altana Pharma/Nycomed
Port Elizabeth, 6001, South Africa
Altana Pharma/Nycomed
Pretoria, 48, South Africa
Altana Pharma/Nycomed
Somerset West, 7130, South Africa
Related Publications (1)
Monnikes H, Schwan T, van Rensburg C, Straszak A, Theek C, Luhmann R, Sander P, Tholen A. Possible etiology of improvements in both quality of life and overlapping gastroesophageal reflux disease by proton pump inhibitor treatment in a prospective randomized controlled trial. BMC Gastroenterol. 2013 Oct 1;13:145. doi: 10.1186/1471-230X-13-145.
PMID: 24083350DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Werner Janssen, MD
23569 Lübeck, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 12, 2006
First Posted
May 15, 2006
Study Start
June 1, 2006
Last Updated
May 7, 2012
Record last verified: 2007-06