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

Gastroesophageal Reflux Disease (GERD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00261300
• Other study ID #: BY1023/VMG-708
• Status: Completed
• Phase: Phase 3
• First received: December 2, 2005
• Last updated: May 4, 2012
• Start date: October 2000
• Est. completion date: July 2008

Study information

• Verified date: December 2008
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease (GERD)
• Peptic Ulcer
• Peptic Ulcers

Intervention

Drug:
• Pantoprazole
Long term Pantoprozole trial

Locations

Country	Name	City	State
Germany	Altana Pharma/Nycomed	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (adverse events, laboratory values).		5 years	Yes
Secondary	Evaluation of gastrointestinal symptoms, histological parameters.		5 years	No