Long-Term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708)
Information source: ALTANA Pharma
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: GERD; Gastroesophageal Reflux Disease; Peptic Ulcers
Intervention: Pantoprazole (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: ALTANA Pharma Official(s) and/or principal investigator(s):
Gorig Brunner, Prof. Dr., Principal Investigator, Affiliation: 30659 Hannover, Germany
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.
Clinical Details
Official title: Long-Term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Primary outcome: Safety (adverse events, laboratory values).
Secondary outcome: Evaluation of gastrointestinal symptoms, histological parameters.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
ALTANA Pharma, Cities in Germany, Germany
Additional Information
Starting date: October 2000
Last updated: February 2, 2007
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