Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-339)
Overview[ - collapse ][ - ]
| Purpose | Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD occurs when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common medical disorders, with estimates of up to 50% of adults reporting symptoms related to gastric reflux. Proton pump inhibitors (PPI) such as pantoprazole can relieve symptoms of GERD in a large proportion of patients. When refluxed stomach acidic content touches the lining of the esophagus, it causes a burning sensation in the chest or throat. This sensation is often referred to as heartburn. Some patients have symptoms of GERD without visible destruction of the tissue surface (no visible changes by endoscopic examination). The aim of the study is to evaluate the effect of pantoprazole on the complete remission of GERD. Complete remission is defined as endoscopically confirmed healing and symptom relief after a maximum of 12-week treatment period. Pantoprazole will be administered once daily in the morning. Endoscopy will be performed at the start of the study, and then as required after 4, 8, or 12 weeks. The study will provide further data on safety and tolerability of pantoprazole. |
|---|---|
| Condition | Gastroesophageal Reflux |
| Intervention | Drug: Pantoprazole |
| Phase | Phase 3 |
| Sponsor | Takeda |
| Responsible Party | Takeda |
| ClinicalTrials.gov Identifier | NCT00163306 |
| First Received | September 12, 2005 |
| Last Updated | May 4, 2012 |
| Last verified | May 2007 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 12, 2005 |
|---|---|
| Last Updated Date | May 4, 2012 |
| Start Date | May 2005 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | complete reflux disease remission rate after 8 weeks of treatment defined as symptom relief assessed by reflux questionnaire (ReQuest Trademark) and endoscopically confirmed healing. |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-339) |
|---|---|
| Official Title | Complete Remission: Evaluation of the Complete Remission Rates in Patients With Symptomatic Non-erosive Reflux Disease (NERD) or Erosive Gastroesophageal Reflux Disease (GERD) Treated With Pantoprazole 40 Milligram o.d. Over 4 or 8 or 12 Weeks |
| Brief Summary | Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD occurs when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common medical disorders, with estimates of up to 50% of adults reporting symptoms related to gastric reflux. Proton pump inhibitors (PPI) such as pantoprazole can relieve symptoms of GERD in a large proportion of patients. When refluxed stomach acidic content touches the lining of the esophagus, it causes a burning sensation in the chest or throat. This sensation is often referred to as heartburn. Some patients have symptoms of GERD without visible destruction of the tissue surface (no visible changes by endoscopic examination). The aim of the study is to evaluate the effect of pantoprazole on the complete remission of GERD. Complete remission is defined as endoscopically confirmed healing and symptom relief after a maximum of 12-week treatment period. Pantoprazole will be administered once daily in the morning. Endoscopy will be performed at the start of the study, and then as required after 4, 8, or 12 weeks. 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, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Gastroesophageal Reflux |
| Intervention | Drug: Pantoprazole |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 1200 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Main Inclusion Criteria: - Outpatients - Reflux disease-related symptoms for at least 12 weeks, which need not be consecutive, in the previous 12 months or endoscopically confirmed reflux esophagitis grade A to D, according to LA-classification Main Exclusion Criteria: - Regular intake of systemic glucocorticosteroids, NSAIDs including COX-2 inhibitors on >3 consecutive days per week within the previous 28 days; exception: regular intake of acetylsalicylic acid up to a daily dose of 150 mg/day - Intake of PPIs (proton pump inhibitor) during the last 10 days, of histamine 2-receptor antagonists or prokinetics during the last 5 days, intake of sucralfate during the last 2 days before the start of the study - Intake of PPIs in combination with antibiotics for eradication of H. pylori during the last 28 days prior to study start - Eradication of H. pylori during the last 28 days prior to study start - Acute peptic ulcer and/or ulcer complications |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Austria, Germany, Hungary, Poland |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00163306 |
|---|---|
| Other Study ID Numbers | BY1023/M3-339 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Takeda |
| Study Sponsor | Takeda |
| Collaborators | Not Provided |
| Investigators | Study Chair: Hartmut Heinze, MD Altana Pharma AG, D-78467 Konstanz, Germany, info.clintrials@altanapharma.com |
| Verification Date | May 2007 |
Locations[ + expand ][ + ]
| Altana Pharma/Nycomed | Deutschlandsberg, Austria, 8539 |
|---|---|
| Altana Pharma/Nycomed | Feldbach, Austria, 8330 |
| Altana Pharma/Nycomed | Graz, Austria, 8010 |
| Altana Pharma/Nycomed | Graz, Austria, 8020 |
| Altana Pharma/Nycomed | Krems a. d. Donau, Austria, 3500 |
| Altana Pharma/Nycomed | Lilienfeld, Austria, 3180 |
| Altana Pharma/Nycomed | Stockerau, Austria, 2000 |
| Altana Pharma/Nycomed | Wien, Austria, 1170 |
| Altana Pharma/Nycomed | Wien, Austria, 1130 |
| 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 | Bad Bramstedt, Germany, 24576 |
| Altana Pharma/Nycomed | Bad Schwalbach, Germany, 65307 |
| Altana Pharma/Nycomed | Beckum, Germany, 59269 |
| Altana Pharma/Nycomed | Berlin, Germany, 12587 |
| Altana Pharma/Nycomed | Berlin, Germany, 13581 |
| Altana Pharma/Nycomed | Berlin, Germany, 10409 |
| Altana Pharma/Nycomed | Flensburg, Germany, 24937 |
| Altana Pharma/Nycomed | Freiburg, Germany, 79098 |
| Altana Pharma/Nycomed | Freising, Germany, 85356 |
| Altana Pharma/Nycomed | Germersheim, Germany, 76726 |
| Altana Pharma/Nycomed | Hamburg, Germany, 22335 |
| Altana Pharma/Nycomed | Haßfurt, Germany, 97437 |
| Altana Pharma/Nycomed | Herzogenrath, Germany, 52134 |
| Altana Pharma/Nycomed | Jülich, Germany, 52428 |
| Altana Pharma/Nycomed | Kirchheimbolanden, Germany, 67292 |
| Altana Pharma/Nycomed | Landsberg, Germany, 6188 |
| Altana Pharma/Nycomed | Langen, Germany, 63225 |
| Altana Pharma/Nycomed | Leipzig, Germany, 4105 |
| Altana Pharma/Nycomed | Ludwigsburg, Germany, 71640 |
| Altana Pharma/Nycomed | Ludwigshafen, Germany, 67067 |
| Altana Pharma/Nycomed | Lübeck, Germany, 23569 |
| Altana Pharma/Nycomed | Lütjenburg, Germany, 24321 |
| Altana Pharma/Nycomed | Magdeburg, Germany, 39114 |
| Altana Pharma/Nycomed | Magdeburg, Germany, 39130 |
| Altana Pharma/Nycomed | Mönchengladbach, Germany, 41239 |
| Altana Pharma/Nycomed | München, Germany, 81669 |
| Altana Pharma/Nycomed | München, Germany, 80337 |
| Altana Pharma/Nycomed | Nieder-Olm, Germany, 55268 |
| Altana Pharma/Nycomed | Oelde, Germany, 59302 |
| Altana Pharma/Nycomed | Potsdam-Babelsberg, Germany, 14482 |
| Altana Pharma/Nycomed | Reinfeld, Germany, 23858 |
| Altana Pharma/Nycomed | Rottweil, Germany, 78628 |
| Altana Pharma/Nycomed | Saarbrücken, Germany, 66111 |
| Altana Pharma/Nycomed | Schweinfurt, Germany, 97421 |
| Altana Pharma/Nycomed | Stuttgart, Germany, 70565 |
| Altana Pharma/Nycomed | Tessin, Germany, 18195 |
| Altana Pharma/Nycomed | Wiesbaden, Germany, 65189 |
| Altana Pharma/Nycomed | Wolfsburg, Germany, 38448 |
| Altana Pharma/Nycomed | Wolmirstedt, Germany, 39326 |
| Altana Pharma/Nycomed | Budapest, Hungary, 1032 |
| Altana Pharma/Nycomed | Budapest, Hungary, 1062 |
| Altana Pharma/Nycomed | Budapest, Hungary, 1085 |
| Altana Pharma/Nycomed | Budapest, Hungary, 1115 |
| Altana Pharma/Nycomed | Gyula, Hungary, 5700 |
| Altana Pharma/Nycomed | Györ, Hungary, 9024 |
| Altana Pharma/Nycomed | Hatvan, Hungary, 3000 |
| Altana Pharma/Nycomed | Kaposvár, Hungary, 7400 |
| Altana Pharma/Nycomed | Miskolc, Hungary, 3526 |
| Altana Pharma/Nycomed | Pécs, Hungary, 7632 |
| Altana Pharma/Nycomed | Szeged, Hungary, 6720 |
| Altana Pharma/Nycomed | Szekesfehervar, Hungary, 8000 |
| Altana Pharma/Nycomed | Szekszárd, Hungary, 7100 |
| Altana Pharma/Nycomed | Szentes, Hungary, 6600 |
| Altana Pharma/Nycomed | Szombathely, Hungary, 9701 |
| Altana Pharma/Nycomed | Tatabanya, Hungary, 2800 |
| Altana Pharma/Nycomed | Vác, Hungary, 2601 |
| Altana Pharma/Nycomed | Bydgoszcz, Poland, 85-168 |
| Altana Pharma/Nycomed | Drezdenko, Poland, 66-530 |
| Altana Pharma/Nycomed | Kielce, Poland, 25-513 |
| Altana Pharma/Nycomed | Kraków, Poland, 31-153 |
| Altana Pharma/Nycomed | Rzeszow, Poland, 35-068 |
| Altana Pharma/Nycomed | Rzeszow, Poland, 35025 |
| Altana Pharma/Nycomed | Slupsk, Poland, 76200 |
| Altana Pharma/Nycomed | Sopot, Poland, 81-756 |
| Altana Pharma/Nycomed | Torun, Poland, 87-100 |
| Altana Pharma/Nycomed | Tychy, Poland, 43-100 |