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

Phase 3

Completed

• Conditions: Gastroesophageal Reflux Disease (GERD); Peptic Ulcers
• Interventions: Drug: Pantoprazole

• Registration Number: NCT00261300
• Lead Sponsor: Takeda

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-10
• Study First Submitted: 2005-12-02
• Study First Submitted QC: 2005-12-02
• Study First Posted: 2005-12-05
• Primary Completion: 2007-09
• Study Completion: 2008-07
• Status Verified: 2008-12
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Pantoprazole	Pantoprazole 40 mg

Primary Outcome Measures

Name	Time	Method
Safety (adverse events, laboratory values).	5 years

Secondary Outcome Measures

Name	Time	Method
Evaluation of gastrointestinal symptoms, histological parameters.	5 years

Trial Locations

Locations (1)

Altana Pharma/Nycomed; 🇩🇪 Hannover, Germany