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

NCT ID: NCT00261300

Last Updated: 2012-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-10-31
• Study Completion Date: 2008-07-31

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.

Conditions

Gastroesophageal Reflux Disease (GERD); Peptic Ulcers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Pantoprazole 40 mg

Group Type: EXPERIMENTAL

Pantoprazole

Intervention Type: DRUG

Long term Pantoprozole trial

Interventions

Pantoprazole

Long term Pantoprozole trial

Intervention Type: DRUG

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Nycomed

Principal Investigators

Gorig Brunner, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

30659 Hannover, Germany

Locations

Altana Pharma/Nycomed

Hanover, , Germany

Countries

Germany

Other Identifiers

BY1023/VMG-708

Identifier Type: -

Identifier Source: org_study_id