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

Takeda

Status and phase: Completed; Phase 3

Conditions: Peptic Ulcers; Gastroesophageal Reflux Disease (GERD)

Treatments: Drug: Pantoprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00261300

BY1023/VMG-708

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

1

Experimental group

Description:

Pantoprazole 40 mg

Treatment:

Drug: Pantoprazole