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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 2, 2005 | ||||
| Last Updated Date | January 8, 2009 | ||||
| Start Date ICMJE | October 2000 | ||||
| Primary Completion Date | September 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Safety (adverse events, laboratory values). [ Time Frame: 5 years ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Safety (adverse events, laboratory values). | ||||
| Change History | Complete list of historical versions of study NCT00261300 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Evaluation of gastrointestinal symptoms, histological parameters. [ Time Frame: 5 years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Evaluation of gastrointestinal symptoms, histological parameters. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Long-Term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708) | ||||
| Official Title ICMJE | 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. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Pantoprazole | ||||
| Study Arms / Comparison Groups | Experimental: Pantoprazole 40 mg | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | July 2008 | ||||
| Primary Completion Date | September 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Main Inclusion Criteria:
Main Exclusion Criteria:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00261300 | ||||
| Responsible Party | Nycomed, Nycomed | ||||
| Study ID Numbers ICMJE | BY1023/VMG-708 | ||||
| Study Sponsor ICMJE | ALTANA Pharma | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | ALTANA Pharma | ||||
| Verification Date | December 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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