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

Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and oesophagus. GERD might occur when the lower oesophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the oesophagus. 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 oesophagus, 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.

Official Title

Long-Term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints.

Conditions

• GERD
• Gastroesophageal Reflux Disease
• Peptic Ulcers

Study Type

Interventional

Study Design

Treatment, Non-Randomised, Open Label, Uncontrolled, Single Group Assignment.

 

 

 

 

Further Details

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]

Study Start

October 2000

Eligibility & Criteria

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

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

Exclusion Criteria:

• Concomitant diseases
• Pregnant or nursing female patients; female patients of childbearing potential who are not using reliable contraception.

Total Enrolment

100

Contact Details

Gorig Brunner, (Prof. Dr.)
Hannover, Germany, 30659

Location:

Altana Pharma/Nycomed
Hannover, Germany, 30659