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Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708)

This study has been completed.
Sponsor:
Information provided by:
Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:
NCT00261300
First received: December 2, 2005
Last updated: May 4, 2012
Last verified: December 2008
History of Changes
  Purpose

Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD might occur 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 reflux symptoms. One of the main symptoms of GERD is heartburn. It occurs when the acidic content from the stomach touches the lining of the esophagus, causing a burning sensation in the chest or throat. Proton pump inhibitors such as pantoprazole can relieve symptoms of GERD and peptic ulcers in a large proportion of patients.

Additionally, long-term treatment with proton pump inhibitors may be needed for patients with chronic ulcer disease not caused by H. pylori (H. pylori is a stomach-dwelling bacteria which is often associated with ulcers in the stomach or duodenum).

The aim of the study is to evaluate the long-term effect of pantoprazole in patients with chronic gastric acid-related complaints. The study duration consists of a 5-year treatment period. Pantoprazole will be administered once daily. The study will provide further data on long-term safety, tolerability, and efficacy of pantoprazole.


Condition Intervention Phase
Gastroesophageal Reflux Disease (GERD)
Peptic Ulcers
 Drug: Pantoprazole
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints

Resource links provided by NLM:

MedlinePlus related topics: GERD Peptic Ulcer
U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:
  • Safety (adverse events, laboratory values). [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of gastrointestinal symptoms, histological parameters. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2000
Study Completion Date: July 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Pantoprazole 40 mg
 Drug: Pantoprazole
Long term Pantoprozole trial

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Patients who completed ALTANA Pharma study BY1023/FK3006 (long-term clinical trial regarding efficacy and tolerability of Pantoprazole in patients not responding to treatment with H2-receptor antagonists or omeprazole)
  • Written informed consent

Main Exclusion Criteria:

  • Concomitant diseases
  • Pregnant or nursing female patients; female patients of childbearing potential who are not using reliable contraception
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00261300

Locations
Germany
Altana Pharma/Nycomed
Hannover, Germany, 30659
Sponsors and Collaborators
Takeda Global Research & Development Center, Inc.
Investigators
Principal Investigator: Gorig Brunner, Prof. Dr. 30659 Hannover, Germany
  More Information

No publications provided

Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT00261300     History of Changes
Other Study ID Numbers: BY1023/VMG-708
Study First Received: December 2, 2005
Last Updated: May 4, 2012
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)

Keywords provided by Takeda Global Research & Development Center, Inc.:
Gastric acid
GERD
Gastroesophageal reflux disease
Pantoprazole
Proton pump inhibitor

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

ClinicalTrials.gov processed this record on May 16, 2013