Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Non-erosive Reflux or Gastroesophageal Reflux Disease (BY1023/DE-004)
This study has been completed.
Sponsor:
Nycomed: A Takeda Company
Information provided by:
Nycomed: A Takeda Company
ClinicalTrials.gov Identifier:
NCT00326027
First received: May 15, 2006
Last updated: May 4, 2012
Last verified: May 2012
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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 | Intervention | Phase |
|---|---|---|
|
Gastroesophageal Reflux |
Drug: Pantoprazole |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Nycomed: A Takeda Company:
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 ]
Secondary Outcome Measures:
- Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI (gastrointestinal) after 2 to 7 days of treatment [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Symptom relief rates as measured by ReQuest™ after 7 days of treatment [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Safety [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 29 |
| Study Start Date: | October 2006 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Pantoprazole 20 mg
|
Drug: Pantoprazole
Efficacy of Pantoprazole
|
|
Active Comparator: 2
Pantoprazole 40 mg
|
Drug: Pantoprazole
Efficacy of Pantoprazole
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00326027
Locations
| Germany | |
| 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 | |
Sponsors and Collaborators
Nycomed: A Takeda Company
Investigators
| Principal Investigator: | Joachim Mössner, Prof. | Universitätsklinikum Leipzig, Leipzig, Germany |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00326027 History of Changes |
| Other Study ID Numbers: | BY1023/DE-004 |
| Study First Received: | May 15, 2006 |
| Last Updated: | May 4, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Nycomed: A Takeda Company:
|
GERD Pantoprazole NERD |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Pantoprazole |
Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013