Symptom Assessment in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) or enGERD (Endoscopic-negative GERD) After Treatment With Pantoprazole (BY1023/M3-343)
Overview[ - collapse ][ - ]
| Purpose | The aim of this study is to compare investigator and patient-assessed gastroesophageal reflux disease symptoms in patients with erosive GERD or endoscopic-negative GERD (enGERD). An endoscopy will be performed at study start and study end. During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™ questionnaire). The study duration consists of a baseline period (8 days) and treatment period (28 days). Pantoprazole (tablet) will be administered once daily at one dose level. The study will provide further data on safety and tolerability of pantoprazole. |
|---|---|
| Condition | GERD |
| Intervention | Drug: Pantoprazole |
| Phase | Phase 3 |
| Sponsor | Takeda |
| Responsible Party | Takeda |
| ClinicalTrials.gov Identifier | NCT00336219 |
| First Received | June 12, 2006 |
| Last Updated | May 4, 2012 |
| Last verified | October 2008 |
Tracking Information[ + expand ][ + ]
| First Received Date | June 12, 2006 |
|---|---|
| Last Updated Date | May 4, 2012 |
| Start Date | August 2006 |
| Estimated Primary Completion Date | April 2007 |
| Current Primary Outcome Measures | symptom assessment as measured by ReQuest™ questionnaire and investigator. [Time Frame: 28 days] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | Symptom Assessment in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) or enGERD (Endoscopic-negative GERD) After Treatment With Pantoprazole (BY1023/M3-343) |
|---|---|
| Official Title | COMPETITION: Investigation of Clinical Endpoints for Treatment-induced Gastroesophageal Reflux Disease (GERD) Symptom Changes |
| Brief Summary | The aim of this study is to compare investigator and patient-assessed gastroesophageal reflux disease symptoms in patients with erosive GERD or endoscopic-negative GERD (enGERD). An endoscopy will be performed at study start and study end. During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™ questionnaire). The study duration consists of a baseline period (8 days) and treatment period (28 days). Pantoprazole (tablet) will be administered once daily at one dose level. The study will provide further data on safety and tolerability of pantoprazole. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | GERD |
| Intervention | Drug: Pantoprazole Symptom Assessment after treatment with Pantoprozole 40 mg |
| Study Arm (s) | Active Comparator: 1 Pantoprazole 40 mg |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 628 |
| Estimated Completion Date | April 2007 |
| Estimated Primary Completion Date | November 2006 |
| Eligibility Criteria | Main Inclusion Criteria: - Written informed consent - Outpatients - History of GERD-related symptoms for at least 6 months prior to study inclusion - Endoscopically confirmed erosive GERD or non-erosive GERD Main Exclusion Criteria: - Acute peptic ulcer and/or ulcer complications - PPIs during last 7 days prior to study start - Systemic glucocorticoids or non-steroidal anti-inflammatory drugs including COX-2 inhibitors during the last 28 days prior to study start; except regular intake of acetylsalicylic acid up to a daily dose of 163 mg/day - Intake of PPIs in combination with antibiotics for eradication of H. pylori |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Australia, Austria, Germany, Hungary |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00336219 |
|---|---|
| Other Study ID Numbers | BY1023/M3-343 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Takeda |
| Study Sponsor | Takeda |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Gerald Holtmann, Prof. Department of Gastroenterology, Hepatology and General Medicine, Royal Adelaide Hospital, North Terrace, Adelaide, Australia |
| Verification Date | October 2008 |
Locations[ + expand ][ + ]
| Altana Pharma/Nycomed | Bondi Junction, Australia, NSW 2022 |
|---|---|
| Altana Pharma/Nycomed | Box Hill, Victoria, Australia, 3128 |
| Altana Pharma/Nycomed | New South Wales, Australia, 2138 |
| Altana Pharma/Nycomed | South Australia, Australia, 5000 |
| Altana Pharma/Nycomed | Feldbach, Austria, 8330 |
| Altana Pharma/Nycomed | Graz, Austria, 8020 |
| Altana Pharma/Nycomed | Stockerau, Austria, 2000 |
| Altana Pharma/Nycomed | Wien, Austria, 1140 |
| Altana Pharma/Nycomed | Wiener Neustadt, Austria, 2700 |
| Altana Pharma/Nycomed | Amberg, Germany, 92224 |
| Altana Pharma/Nycomed | Aschersleben, Germany, 6449 |
| Altana Pharma/Nycomed | Berlin, Germany, 10409 |
| Altana Pharma/Nycomed | Berlin, Germany, 12587 |
| Altana Pharma/Nycomed | Berlin, Germany, 13581 |
| Altana Pharma/Nycomed | Freising, Germany, 85356 |
| Altana Pharma/Nycomed | Germersheim, Germany, 76726 |
| Altana Pharma/Nycomed | Grünstadt, Germany, 67269 |
| Altana Pharma/Nycomed | Jülich, Germany, 52428 |
| Altana Pharma/Nycomed | Köln, Germany, 50999 |
| Altana Pharma/Nycomed | Köln, Germany, 51065 |
| Altana Pharma/Nycomed | Köthen, Germany, 6366 |
| Altana Pharma/Nycomed | Künzing, Germany, 94550 |
| Altana Pharma/Nycomed | Landsberg, Germany, 6188 |
| Altana Pharma/Nycomed | Langen, Germany, 63225 |
| Altana Pharma/Nycomed | Leipzig, Germany, 4105 |
| Altana Pharma/Nycomed | Ludwigshafen, Germany, 67067 |
| Altana Pharma/Nycomed | Lüneburg, Germany, 21335 |
| Altana Pharma/Nycomed | Mönchengladbach, Germany, 41239 |
| Altana Pharma/Nycomed | München, Germany, 80639 |
| Altana Pharma/Nycomed | Potsdam-Babelsberg, Germany, 14482 |
| Altana Pharma/Nycomed | Reinfeld, Germany, 23858 |
| Altana Pharma/Nycomed | Saarbrücken, Germany, 66111 |
| Altana Pharma/Nycomed | Budapest, Hungary, 1125 |
| Altana Pharma/Nycomed | Györ, Hungary, 9024 |
| Altana Pharma/Nycomed | Hatvan, Hungary, 3000 |
| Altana Pharma/Nycomed | Kaposvár, Hungary, 7400 |
| Altana Pharma/Nycomed | Kistarcsa, Hungary, 2143 |
| Altana Pharma/Nycomed | Miskolc, Hungary, 3526 |
| Altana Pharma/Nycomed | Szentes, Hungary, 6600 |
| Altana Pharma/Nycomed | Vác, Hungary, 2601 |