Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708)
Overview[ - collapse ][ - ]
| Purpose | Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD might occur 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 reflux symptoms. One of the main symptoms of GERD is heartburn. It occurs when the acidic content from the stomach touches the lining of the esophagus, causing a burning sensation in the chest or throat. Proton pump inhibitors such as pantoprazole can relieve symptoms of GERD and peptic ulcers in a large proportion of patients. Additionally, long-term treatment with proton pump inhibitors may be needed for patients with chronic ulcer disease not caused by H. pylori (H. pylori is a stomach-dwelling bacteria which is often associated with ulcers in the stomach or duodenum). The aim of the study is to evaluate the long-term effect of pantoprazole in patients with chronic gastric acid-related complaints. The study duration consists of a 5-year treatment period. Pantoprazole will be administered once daily. The study will provide further data on long-term safety, tolerability, and efficacy of pantoprazole. |
|---|---|
| Condition | Gastroesophageal Reflux Disease (GERD) Peptic Ulcers |
| Intervention | Drug: Pantoprazole |
| Phase | Phase 3 |
| Sponsor | Takeda |
| Responsible Party | Takeda |
| ClinicalTrials.gov Identifier | NCT00261300 |
| First Received | December 2, 2005 |
| Last Updated | May 4, 2012 |
| Last verified | December 2008 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 2, 2005 |
|---|---|
| Last Updated Date | May 4, 2012 |
| Start Date | October 2000 |
| Estimated Primary Completion Date | July 2008 |
| Current Primary Outcome Measures | Safety (adverse events, laboratory values). [Time Frame: 5 years] [Designated as safety issue: Yes] |
| Current Secondary Outcome Measures | Evaluation of gastrointestinal symptoms, histological parameters. [Time Frame: 5 years] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708) |
|---|---|
| Official Title | Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints |
| Brief Summary | Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD might occur 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 reflux symptoms. One of the main symptoms of GERD is heartburn. It occurs when the acidic content from the stomach touches the lining of the esophagus, causing a burning sensation in the chest or throat. Proton pump inhibitors such as pantoprazole can relieve symptoms of GERD and peptic ulcers in a large proportion of patients. Additionally, long-term treatment with proton pump inhibitors may be needed for patients with chronic ulcer disease not caused by H. pylori (H. pylori is a stomach-dwelling bacteria which is often associated with ulcers in the stomach or duodenum). The aim of the study is to evaluate the long-term effect of pantoprazole in patients with chronic gastric acid-related complaints. The study duration consists of a 5-year treatment period. Pantoprazole will be administered once daily. The study will provide further data on long-term safety, tolerability, and efficacy 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 |
|
| Intervention | Drug: Pantoprazole Long term Pantoprozole trial |
| Study Arm (s) | Experimental: 1 Pantoprazole 40 mg |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 100 |
| Estimated Completion Date | July 2008 |
| Estimated Primary Completion Date | September 2007 |
| Eligibility Criteria | Main Inclusion Criteria: - Patients who completed ALTANA Pharma study BY1023/FK3006 (long-term clinical trial regarding efficacy and tolerability of Pantoprazole in patients not responding to treatment with H2-receptor antagonists or omeprazole) - Written informed consent Main Exclusion Criteria: - Concomitant diseases - Pregnant or nursing female patients; female patients of childbearing potential who are not using reliable contraception |
| Gender | Both |
| Ages | N/A |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Germany |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00261300 |
|---|---|
| Other Study ID Numbers | BY1023/VMG-708 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Takeda |
| Study Sponsor | Takeda |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Gorig Brunner, Prof. Dr. 30659 Hannover, Germany |
| Verification Date | December 2008 |
Locations[ + expand ][ + ]
| Altana Pharma/Nycomed | Hannover, Germany, 30659 |
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