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

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00163306
First received: September 12, 2005
Last updated: May 4, 2012
Last verified: May 2007
  Purpose

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 Intervention Phase
Gastroesophageal Reflux
Drug: Pantoprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 1200
Study Start Date: May 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163306

  Show 79 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Hartmut Heinze, MD Altana Pharma AG, D-78467 Konstanz, Germany, info.clintrials@altanapharma.com
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00163306     History of Changes
Other Study ID Numbers: BY1023/M3-339
Study First Received: September 12, 2005
Last Updated: May 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Takeda:
Gastroesophageal Reflux
Gastroesophageal Reflux Disease
Pantoprazole

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

ClinicalTrials.gov processed this record on October 23, 2014