Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-339)

NCT00163306 | Completed Phase 3

• 1 other identifier: BY1023/M3-339
• Study Type: interventional
• Target: 1,200
• Locations: 4 countries
• Sites: 79

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.

Conditions

Gastroesophageal Reflux

Keywords

Gastroesophageal Reflux; Gastroesophageal Reflux Disease; Pantoprazole

Outcome Measures

Primary Outcomes (1)

• complete reflux disease remission rate after 8 weeks of treatment defined as symptom relief assessed by reflux questionnaire (ReQuest Trademark) and endoscopically confirmed healing.

Secondary Outcomes (11)

• complete reflux disease remission rates after 4, 8, and 12 weeks

• time to reach first complete remission

• time to reach sustained complete remission

• time to reach first symptom relief that is based on the pre-defined GERD symptoms threshold of the reflux questionnaire

• average symptom load above pre-defined GERD symptoms threshold

Interventions

Pantoprazole DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Takeda: lead

Study Sites (79)

Altana Pharma/Nycomed

Deutschlandsberg, 8539, Austria

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Altana Pharma/Nycomed

Feldbach, 8330, Austria

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Altana Pharma/Nycomed

Graz, 8010, Austria

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Altana Pharma/Nycomed

Graz, 8020, Austria

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Altana Pharma/Nycomed

Krems A. D. Donau, 3500, Austria

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Altana Pharma/Nycomed

Lilienfeld, 3180, Austria

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Altana Pharma/Nycomed

Stockerau, 2000, Austria

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Altana Pharma/Nycomed

Vienna, 1130, Austria

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Altana Pharma/Nycomed

Vienna, 1140, Austria

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Altana Pharma/Nycomed

Vienna, 1170, Austria

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Altana Pharma/Nycomed

Wiener Neustadt, 2700, Austria

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Altana Pharma/Nycomed

Amberg, 92224, Germany

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Altana Pharma/Nycomed

Aschersleben, 6449, Germany

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Altana Pharma/Nycomed

Bad Bramstedt, 24576, Germany

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Altana Pharma/Nycomed

Bad Schwalbach, 65307, Germany

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Altana Pharma/Nycomed

Beckum, 59269, Germany

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Altana Pharma/Nycomed

Berlin, 10409, Germany

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Altana Pharma/Nycomed

Berlin, 12587, Germany

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Altana Pharma/Nycomed

Berlin, 13581, Germany

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Altana Pharma/Nycomed

Flensburg, 24937, Germany

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Altana Pharma/Nycomed

Freiburg im Breisgau, 79098, Germany

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Altana Pharma/Nycomed

Freising, 85356, Germany

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Altana Pharma/Nycomed

Germersheim, 76726, Germany

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Altana Pharma/Nycomed

Hamburg, 22335, Germany

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Altana Pharma/Nycomed

Haßfurt, 97437, Germany

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Altana Pharma/Nycomed

Herzogenrath, 52134, Germany

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Altana Pharma/Nycomed

Jülich, 52428, Germany

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Altana Pharma/Nycomed

Kirchheimbolanden, 67292, Germany

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Altana Pharma/Nycomed

Landsberg, 6188, Germany

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Altana Pharma/Nycomed

Langen, 63225, Germany

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Altana Pharma/Nycomed

Leipzig, 4105, Germany

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Altana Pharma/Nycomed

Ludwigsburg, 71640, Germany

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Altana Pharma/Nycomed

Ludwigshafen, 67067, Germany

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Altana Pharma/Nycomed

Lübeck, 23569, Germany

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Altana Pharma/Nycomed

Lütjenburg, 24321, Germany

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Altana Pharma/Nycomed

Magdeburg, 39114, Germany

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Altana Pharma/Nycomed

Magdeburg, 39130, Germany

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Altana Pharma/Nycomed

Mönchengladbach, 41239, Germany

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Altana Pharma/Nycomed

München, 80337, Germany

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Altana Pharma/Nycomed

München, 81669, Germany

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Altana Pharma/Nycomed

Nieder-Olm, 55268, Germany

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Altana Pharma/Nycomed

Oelde, 59302, Germany

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Altana Pharma/Nycomed

Potsdam-Babelsberg, 14482, Germany

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Altana Pharma/Nycomed

Reinfeld, 23858, Germany

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Altana Pharma/Nycomed

Rottweil, 78628, Germany

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Altana Pharma/Nycomed

Saarbrücken, 66111, Germany

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Altana Pharma/Nycomed

Schweinfurt, 97421, Germany

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Altana Pharma/Nycomed

Stuttgart, 70565, Germany

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Altana Pharma/Nycomed

Tessin, 18195, Germany

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Altana Pharma/Nycomed

Wiesbaden, 65189, Germany

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Altana Pharma/Nycomed

Wolfsburg, 38448, Germany

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Altana Pharma/Nycomed

Wolmirstedt, 39326, Germany

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Altana Pharma/Nycomed

Budapest, 1032, Hungary

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Altana Pharma/Nycomed

Budapest, 1062, Hungary

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Altana Pharma/Nycomed

Budapest, 1085, Hungary

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Altana Pharma/Nycomed

Budapest, 1115, Hungary

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Altana Pharma/Nycomed

Győr, 9024, Hungary

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Altana Pharma/Nycomed

Gyula, 5700, Hungary

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Altana Pharma/Nycomed

Hatvan, 3000, Hungary

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Altana Pharma/Nycomed

Kaposvár, 7400, Hungary

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Altana Pharma/Nycomed

Miskolc, 3526, Hungary

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Altana Pharma/Nycomed

Pécs, 7632, Hungary

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Altana Pharma/Nycomed

Szeged, 6720, Hungary

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Altana Pharma/Nycomed

Szekszárd, 7100, Hungary

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Altana Pharma/Nycomed

Szentes, 6600, Hungary

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Altana Pharma/Nycomed

Székesfehérvár, 8000, Hungary

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Altana Pharma/Nycomed

Szombathely, 9701, Hungary

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Altana Pharma/Nycomed

Tatabánya, 2800, Hungary

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Altana Pharma/Nycomed

Vác, 2601, Hungary

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Altana Pharma/Nycomed

Bydgoszcz, 85-168, Poland

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Altana Pharma/Nycomed

Drezdenko, 66-530, Poland

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Altana Pharma/Nycomed

Kielce, 25-513, Poland

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Altana Pharma/Nycomed

Krakow, 31-153, Poland

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Altana Pharma/Nycomed

Rzeszów, 35-068, Poland

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Altana Pharma/Nycomed

Rzeszów, 35025, Poland

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Altana Pharma/Nycomed

Sopot, 81-756, Poland

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Altana Pharma/Nycomed

Słupsk, 76200, Poland

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Altana Pharma/Nycomed

Torun, 87-100, Poland

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Altana Pharma/Nycomed

Tychy, 43-100, Poland

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hartmut Heinze, MD

  Altana Pharma AG, D-78467 Konstanz, Germany, info.clintrials@altanapharma.com

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: May 1, 2005
• Last Updated: May 7, 2012

Record last verified: 2007-05

Locations

HU (17); DE (41); AU (11); PL (10)