Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-339)
NCT ID: NCT00163306
Last Updated: 2012-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1200 participants
INTERVENTIONAL
2005-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Pantoprazole
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Principal Investigators
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Locations
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Altana Pharma/Nycomed
Deutschlandsberg, , Austria
Altana Pharma/Nycomed
Feldbach, , Austria
Altana Pharma/Nycomed
Graz, , Austria
Altana Pharma/Nycomed
Graz, , Austria
Altana Pharma/Nycomed
Krems A. D. Donau, , Austria
Altana Pharma/Nycomed
Lilienfeld, , Austria
Altana Pharma/Nycomed
Stockerau, , Austria
Altana Pharma/Nycomed
Vienna, , Austria
Altana Pharma/Nycomed
Vienna, , Austria
Altana Pharma/Nycomed
Vienna, , Austria
Altana Pharma/Nycomed
Wiener Neustadt, , Austria
Altana Pharma/Nycomed
Amberg, , Germany
Altana Pharma/Nycomed
Aschersleben, , Germany
Altana Pharma/Nycomed
Bad Bramstedt, , Germany
Altana Pharma/Nycomed
Bad Schwalbach, , Germany
Altana Pharma/Nycomed
Beckum, , Germany
Altana Pharma/Nycomed
Berlin, , Germany
Altana Pharma/Nycomed
Berlin, , Germany
Altana Pharma/Nycomed
Berlin, , Germany
Altana Pharma/Nycomed
Flensburg, , Germany
Altana Pharma/Nycomed
Freiburg im Breisgau, , Germany
Altana Pharma/Nycomed
Freising, , Germany
Altana Pharma/Nycomed
Germersheim, , Germany
Altana Pharma/Nycomed
Hamburg, , Germany
Altana Pharma/Nycomed
Haßfurt, , Germany
Altana Pharma/Nycomed
Herzogenrath, , Germany
Altana Pharma/Nycomed
Jülich, , Germany
Altana Pharma/Nycomed
Kirchheimbolanden, , Germany
Altana Pharma/Nycomed
Landsberg, , Germany
Altana Pharma/Nycomed
Langen, , Germany
Altana Pharma/Nycomed
Leipzig, , Germany
Altana Pharma/Nycomed
Ludwigsburg, , Germany
Altana Pharma/Nycomed
Ludwigshafen, , Germany
Altana Pharma/Nycomed
Lübeck, , Germany
Altana Pharma/Nycomed
Lütjenburg, , Germany
Altana Pharma/Nycomed
Magdeburg, , Germany
Altana Pharma/Nycomed
Magdeburg, , Germany
Altana Pharma/Nycomed
Mönchengladbach, , Germany
Altana Pharma/Nycomed
München, , Germany
Altana Pharma/Nycomed
München, , Germany
Altana Pharma/Nycomed
Nieder-Olm, , Germany
Altana Pharma/Nycomed
Oelde, , Germany
Altana Pharma/Nycomed
Potsdam-Babelsberg, , Germany
Altana Pharma/Nycomed
Reinfeld, , Germany
Altana Pharma/Nycomed
Rottweil, , Germany
Altana Pharma/Nycomed
Saarbrücken, , Germany
Altana Pharma/Nycomed
Schweinfurt, , Germany
Altana Pharma/Nycomed
Stuttgart, , Germany
Altana Pharma/Nycomed
Tessin, , Germany
Altana Pharma/Nycomed
Wiesbaden, , Germany
Altana Pharma/Nycomed
Wolfsburg, , Germany
Altana Pharma/Nycomed
Wolmirstedt, , Germany
Altana Pharma/Nycomed
Budapest, , Hungary
Altana Pharma/Nycomed
Budapest, , Hungary
Altana Pharma/Nycomed
Budapest, , Hungary
Altana Pharma/Nycomed
Budapest, , Hungary
Altana Pharma/Nycomed
Győr, , Hungary
Altana Pharma/Nycomed
Gyula, , Hungary
Altana Pharma/Nycomed
Hatvan, , Hungary
Altana Pharma/Nycomed
Kaposvár, , Hungary
Altana Pharma/Nycomed
Miskolc, , Hungary
Altana Pharma/Nycomed
Pécs, , Hungary
Altana Pharma/Nycomed
Szeged, , Hungary
Altana Pharma/Nycomed
Szekszárd, , Hungary
Altana Pharma/Nycomed
Szentes, , Hungary
Altana Pharma/Nycomed
Székesfehérvár, , Hungary
Altana Pharma/Nycomed
Szombathely, , Hungary
Altana Pharma/Nycomed
Tatabánya, , Hungary
Altana Pharma/Nycomed
Vác, , Hungary
Altana Pharma/Nycomed
Bydgoszcz, , Poland
Altana Pharma/Nycomed
Drezdenko, , Poland
Altana Pharma/Nycomed
Kielce, , Poland
Altana Pharma/Nycomed
Krakow, , Poland
Altana Pharma/Nycomed
Rzeszów, , Poland
Altana Pharma/Nycomed
Rzeszów, , Poland
Altana Pharma/Nycomed
Sopot, , Poland
Altana Pharma/Nycomed
Słupsk, , Poland
Altana Pharma/Nycomed
Torun, , Poland
Altana Pharma/Nycomed
Tychy, , Poland
Countries
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Other Identifiers
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BY1023/M3-339
Identifier Type: -
Identifier Source: org_study_id
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