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

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ClinicalTrials.gov Identifier: NCT00163306
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : May 7, 2012
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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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Drug: Pantoprazole Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Primary Outcome Measures :
  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 Outcome Measures :
  1. complete reflux disease remission rates after 4, 8, and 12 weeks
  2. time to reach first complete remission
  3. time to reach sustained complete remission
  4. time to reach first symptom relief that is based on the pre-defined GERD symptoms threshold of the reflux questionnaire
  5. average symptom load above pre-defined GERD symptoms threshold
  6. relief rates from reflux disease related complaints after 4, 8 and 12 weeks
  7. endoscopically confirmed healing rates after 4, 8, and 12 weeks
  8. symptom relief rates after 4, 8 and 12 weeks
  9. influence of the H. pylori status on the complete reflux disease remission rate
  10. influence of the H. pylori status on the symptom relief rates
  11. influence of the H. pylori status on the endoscopically confirmed healing rates.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163306

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

ClinicalTrials.gov Identifier: NCT00163306     History of Changes
Other Study ID Numbers: BY1023/M3-339
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: May 2007

Keywords provided by Takeda:
Gastroesophageal Reflux
Gastroesophageal Reflux Disease

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action