Gastroesophageal Reflux Disease Clinical Trial
Official title:
CONFIRM - Confirmation of Superiority of Complete Remission Concept Versus Classical Healing Concept for Treatment of Patients With Erosive GERD
| NCT number | NCT00325676 |
| Other study ID # | BY1023/M3-342 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | May 12, 2006 |
| Last updated | May 4, 2012 |
| Start date | June 2006 |
| Verified date | June 2007 |
| Source | Takeda |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Federal Institute for Drugs and Medical Devices |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 639 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Altana Pharma/Nycomed | Belo Horizonte-MG | |
| Brazil | Altana Pharma/Nycomed | Blumenau - SC | |
| Brazil | Altana Pharma/Nycomed | Botucatu - SP | |
| Brazil | Altana Pharma/Nycomed | Campinas - Sao Paulo | |
| Brazil | Altana Pharma/Nycomed | Campinas - SP | |
| Brazil | Altana Pharma/Nycomed | Curitiba - PR | |
| Brazil | Altana Pharma/Nycomed | Ilha do Fundao - Rio de Janeiro - RJ | |
| Brazil | Altana Pharma/Nycomed | Pinheiros Sao Paulo - SP | |
| Brazil | Altana Pharma/Nycomed | Porto Alegre - RS | |
| Brazil | Altana Pharma/Nycomed | Porto Alegre-RS | |
| Brazil | Altana Pharma/Nycomed | Porto Alegre-RS | |
| Brazil | Altana Pharma/Nycomed | Ribeirao Preto-SP | |
| Brazil | Altana Pharma/Nycomed | Salvador-BA | |
| Brazil | Altana Pharma/Nycomed | Sao Paulo | |
| Germany | Altana Pharma/Nycomed | Bad Schwalbach | |
| Germany | Altana Pharma/Nycomed | Burg | |
| Germany | Altana Pharma/Nycomed | Gardelegen | |
| Germany | Altana Pharma/Nycomed | Königstein | |
| Germany | Altana Pharma/Nycomed | Lübeck | |
| Germany | Altana Pharma/Nycomed | Lüdenscheid | |
| Germany | Altana Pharma/Nycomed | Lütjenburg | |
| Germany | Altana Pharma/Nycomed | Nieder-Olm | |
| Germany | Altana Pharma/Nycomed | Oelde | |
| Germany | Altana Pharma/Nycomed | Wiesbaden | |
| Germany | Altana Pharma/Nycomed | Wolmirstedt | |
| Poland | Altana Pharma/Nycomed | Bydgoszcz | |
| Poland | Altana Pharma/Nycomed | Inowroclaw | |
| Poland | Altana Pharma/Nycomed | Poznan | |
| Poland | Altana Pharma/Nycomed | Siemianowice Slaskie | |
| Poland | Altana Pharma/Nycomed | Torun | |
| Poland | Altana Pharma/Nycomed | Tychy | |
| South Africa | Altana Pharma/Nycomed | Amanzimtoti | |
| South Africa | Altana Pharma/Nycomed | Berea, Durban | |
| South Africa | Altana Pharma/Nycomed | Bloemfontein | |
| South Africa | Altana Pharma/Nycomed | Bloemfontein | |
| South Africa | Altana Pharma/Nycomed | Cape Town | |
| South Africa | Altana Pharma/Nycomed | Durban | |
| South Africa | Altana Pharma/Nycomed | Goodwood | |
| South Africa | Altana Pharma/Nycomed | Johannesburg | |
| South Africa | Altana Pharma/Nycomed | Overport, Durban | |
| South Africa | Altana Pharma/Nycomed | Panorama | |
| South Africa | Altana Pharma/Nycomed | Pinetown | |
| South Africa | Altana Pharma/Nycomed | Port Elizabeth | |
| South Africa | Altana Pharma/Nycomed | Pretoria | |
| South Africa | Altana Pharma/Nycomed | Somerset-West |
| Lead Sponsor | Collaborator |
|---|---|
| Takeda |
Brazil, Germany, Poland, South Africa,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | time to endoscopic relapse and/or unwillingness to continue due to GERD related symptoms | |||
| Secondary | further efficacy criteria | |||
| Secondary | safety |
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