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)
Overview[ - collapse ][ - ]
| 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 | Gastroesophageal Reflux Disease |
| Intervention | Drug: Pantoprazole |
| Phase | Phase 4 |
| Sponsor | Takeda |
| Responsible Party | Takeda |
| ClinicalTrials.gov Identifier | NCT00325676 |
| First Received | May 12, 2006 |
| Last Updated | May 4, 2012 |
| Last verified | June 2007 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 12, 2006 |
|---|---|
| Last Updated Date | May 4, 2012 |
| Start Date | June 2006 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | time to endoscopic relapse and/or unwillingness to continue due to GERD related symptoms |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | 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) |
|---|---|
| Official Title | CONFIRM - Confirmation of Superiority of Complete Remission Concept Versus Classical Healing Concept for Treatment of Patients With Erosive GERD |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Gastroesophageal Reflux Disease |
| Intervention | Drug: Pantoprazole |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 639 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Eligibility 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Brazil, Germany, Poland, South Africa |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00325676 |
|---|---|
| Other Study ID Numbers | BY1023/M3-342 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Takeda |
| Study Sponsor | Takeda |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Werner Janssen, MD 23569 Lübeck, Germany |
| Verification Date | June 2007 |
Locations[ + expand ][ + ]
| 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, 90610000 |
| Altana Pharma/Nycomed | Porto Alegre-RS, Brazil, 90020090 |
| 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 | 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 | 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 | 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 |