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

NCT00261300 | Completed Phase 3

• 1 other identifier: BY1023/VMG-708
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Gastric acid; GERD; Gastroesophageal reflux disease; Pantoprazole; Proton pump inhibitor

Outcome Measures

Primary Outcomes (1)

• Safety (adverse events, laboratory values).

  5 years

Secondary Outcomes (1)

• Evaluation of gastrointestinal symptoms, histological parameters.

  5 years

Study Arms (1)

1

EXPERIMENTAL

Pantoprazole 40 mg

Drug: Pantoprazole

Interventions

Pantoprazole DRUG

Long term Pantoprozole trial

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Concomitant diseases
• Pregnant or nursing female patients; female patients of childbearing potential who are not using reliable contraception

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Altana Pharma/Nycomed

Hanover, 30659, Germany

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Peptic Ulcer

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Gorig Brunner, Prof. Dr.

  30659 Hannover, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 2, 2005
• First Posted: December 5, 2005
• Study Start: October 1, 2000
• Primary Completion: September 1, 2007
• Study Completion: July 1, 2008
• Last Updated: May 7, 2012

Record last verified: 2008-12

Locations

DE (1)