Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Non-erosive Reflux or Gastroesophageal Reflux Disease (BY1023/DE-004)
Overview[ - collapse ][ - ]
| Purpose | The aim of the study is to evaluate the effect of pantoprazole on fast symptom reduction in hospitalized patients with NERD (non-erosive reflux disease) or GERD (gastroesophageal reflux disease, Los Angeles [LA] Grade A-D). During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™). The study duration consists of a treatment period of 7 days ± 3 days. Pantoprazole (tablet) will be administered once daily in the morning to patients with NERD or GERD at one dose level for each indication. The study will provide further data on the safety and tolerability of pantoprazole. |
|---|---|
| Condition | Gastroesophageal Reflux |
| Intervention | Drug: Pantoprazole |
| Phase | Phase 3 |
| Sponsor | Nycomed |
| Responsible Party | Nycomed |
| ClinicalTrials.gov Identifier | NCT00326027 |
| First Received | May 15, 2006 |
| Last Updated | May 4, 2012 |
| Last verified | May 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 15, 2006 |
|---|---|
| Last Updated Date | May 4, 2012 |
| Start Date | October 2006 |
| Estimated Primary Completion Date | November 2007 |
| Current Primary Outcome Measures | Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 1 day of treatment [Time Frame: 1 day] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Non-erosive Reflux or Gastroesophageal Reflux Disease (BY1023/DE-004) |
|---|---|
| Official Title | Profi-Study: Symptom Reduction in Hospitalized Patients Suffering From Symptomatic Non-erosive or Erosive Gastroesophageal Reflux Disease Treated With Pantoprazole 20 or 40 mg o.d. for 7 Days |
| Brief Summary | The aim of the study is to evaluate the effect of pantoprazole on fast symptom reduction in hospitalized patients with NERD (non-erosive reflux disease) or GERD (gastroesophageal reflux disease, Los Angeles [LA] Grade A-D). During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™). The study duration consists of a treatment period of 7 days ± 3 days. Pantoprazole (tablet) will be administered once daily in the morning to patients with NERD or GERD at one dose level for each indication. The study will provide further data on the safety and tolerability of pantoprazole. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Gastroesophageal Reflux |
| Intervention | Drug: Pantoprazole Efficacy of Pantoprazole |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 29 |
| Estimated Completion Date | November 2007 |
| Estimated Primary Completion Date | July 2007 |
| Eligibility Criteria | Main Inclusion Criteria: - Written informed consent - Inpatients (hospitalization during the entire study period is mandatory) - Symptomatic (heartburn, acid regurgitation or dysphagia for at least 1 day since admission to the hospital) non-erosive reflux disease (NERD) or erosive gastroesophageal reflux disease (GERD, LA Grade A-D) Main Exclusion Criteria: - Known Zollinger-Ellison syndrome or other gastric hypersecretory condition - Previous acid-lowering surgery or other surgery of the esophagus and/or upper gastrointestinal tract (exception: polypectomy and cholecystectomy) - On initial endoscopy, presence of obstructive esophageal strictures, Schatzki's ring, esophageal diverticula, esophageal varices, achalasia or Barrett's esophagus with known high-grade dysplasia or longer than 3 cm - Acute peptic ulcer and/or ulcer complications - Pyloric stenosis - Known inflammatory bowel diseases |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Germany |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00326027 |
|---|---|
| Other Study ID Numbers | BY1023/DE-004 |
| Has Data Monitoring Committee | No |
| Information Provided By | Nycomed |
| Study Sponsor | Nycomed |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Joachim Mössner, Prof. Universitätsklinikum Leipzig, Leipzig, Germany |
| Verification Date | May 2012 |
Locations[ + expand ][ + ]
| Nycomed Deutschland GmbH | Augsburg, Germany, 86156 |
|---|---|
| Nycomed Deutschland GmbH | Berlin, Germany, 10117 |
| Nycomed Deutschland GmbH | Brandenburg, Germany, 14770 |
| Nycomed Deutschland GmbH | Erlangen, Germany, 91054 |
| Nycomed Deutschland GmbH | Frankfurt, Germany, 60488 |
| Nycomed Deutschland GmbH | Frankfurt, Germany, 60569 |
| Nycomed Deutschland GmbH | Gera, Germany, 07548 |
| Nycomed Deutschland GmbH | Greifswald, Germany, 17489 |
| Nycomed Deutschland GmbH | Göttingen, Germany, 37075 |
| Nycomed Deutschland GmbH | Halle (Saale), Germany, 06110 |
| Nycomed Deutschland GmbH | Hamburg, Germany, 22457 |
| Nycomed Deutschland GmbH | Hamburg, Germany, 21075 |
| Nycomed Deutschland GmbH | Ingolstadt, Germany, 85049 |
| Nycomed Deutschland GmbH | Jena, Germany, 07747 |
| Nycomed Deutschland GmbH | Kassel, Germany, 34125 |
| Nycomed Deutschland GmbH | Kiel, Germany, 24105 |
| Nycomed Deutschland GmbH | Köln, Germany, 51067 |
| Nycomed Deutschland GmbH | Köln, Germany, 51109 |
| Nycomed Deutschland GmbH | Leipzig, Germany, 04103 |
| Nycomed Deutschland GmbH | Ludwigsburg, Germany, 71640 |
| Nycomed Deutschland GmbH | Ludwigshafen, Germany, 67063 |
| Nycomed Deutschland GmbH | Lübeck, Germany, 23538 |
| Nycomed Deutschland GmbH | Mainz, Germany, 55131 |
| Nycomed Deutschland GmbH | Marburg, Germany, 35043 |
| Nycomed Deutschland GmbH | Minden, Germany, 32427 |
| Nycomed Deutschland GmbH | München, Germany, 81377 |
| Nycomed Deutschland GmbH | Münster, Germany, 48149 |
| Nycomed Deutschland GmbH | Neubrandenburg, Germany, 17036 |
| Nycomed Deutschland GmbH | Offenbach, Germany, 63069 |
| Nycomed Deutschland GmbH | Oldenburg, Germany, 26133 |
| Nycomed Deutschland GmbH | Recklinghausen, Germany, 45655 |
| Nycomed Deutschland GmbH | Rostock, Germany, 18057 |
| Nycomed Deutschland GmbH | Stade, Germany, 21682 |
| Nycomed Deutschland GmbH | Weimar, Germany, 99425 |
| Nycomed Deutschland GmbH | Wiesbaden, Germany, 65189 |