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

May 4, 2012 updated by: Takeda

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • 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, 1130
        • Altana Pharma/Nycomed
      • Wien, Austria, 1140
        • Altana Pharma/Nycomed
      • Wien, Austria, 1170
        • Altana Pharma/Nycomed
      • Wiener Neustadt, Austria, 2700
        • Altana Pharma/Nycomed
  • Germany
      • 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, 10409
        • Altana Pharma/Nycomed
      • Berlin, Germany, 12587
        • Altana Pharma/Nycomed
      • Berlin, Germany, 13581
        • 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, 80337
        • Altana Pharma/Nycomed
      • München, Germany, 81669
        • 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
  • Hungary
      • Budapest, Hungary, 1085
        • Altana Pharma/Nycomed
      • Budapest, Hungary, 1032
        • Altana Pharma/Nycomed
      • Budapest, Hungary, 1062
        • 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
  • Poland
      • 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
        • Altana Pharma/Nycomed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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
relief rates from reflux disease related complaints after 4, 8 and 12 weeks
endoscopically confirmed healing rates after 4, 8, and 12 weeks
symptom relief rates after 4, 8 and 12 weeks
influence of the H. pylori status on the complete reflux disease remission rate
influence of the H. pylori status on the symptom relief rates
influence of the H. pylori status on the endoscopically confirmed healing rates.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Study Chair: Hartmut Heinze, MD, Altana Pharma AG, D-78467 Konstanz, Germany, info.clintrials@altanapharma.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

May 7, 2012

Last Update Submitted That Met QC Criteria

May 4, 2012

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BY1023/M3-339

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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