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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00261300
Recruitment Status : Completed
First Posted : December 5, 2005
Last Update Posted : May 7, 2012
Information provided by:

Brief Summary:

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 or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease (GERD) Peptic Ulcers Drug: Pantoprazole Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints
Study Start Date : October 2000
Actual Primary Completion Date : September 2007
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD Peptic Ulcer

Arm Intervention/treatment
Experimental: 1
Pantoprazole 40 mg
Drug: Pantoprazole
Long term Pantoprozole trial

Primary Outcome Measures :
  1. Safety (adverse events, laboratory values). [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Evaluation of gastrointestinal symptoms, histological parameters. [ Time Frame: 5 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00261300

Altana Pharma/Nycomed
Hannover, Germany, 30659
Sponsors and Collaborators
Principal Investigator: Gorig Brunner, Prof. Dr. 30659 Hannover, Germany

Responsible Party: Nycomed Identifier: NCT00261300     History of Changes
Other Study ID Numbers: BY1023/VMG-708
First Posted: December 5, 2005    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: December 2008

Keywords provided by Takeda:
Gastric acid
Gastroesophageal reflux disease
Proton pump inhibitor

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