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Completed

NCT Number: NCT00261300

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

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.

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Key information

Conditions

Gastroesophageal Reflux Disease (GERD) Deglutition Disorders Digestive System Diseases Duodenal Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Peptic Ulcers Stomach Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Altana Pharma/Nycomed

Hanover, 30659, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pantoprazole

Drug

Long term Pantoprozole trial

Primary outcomes

  1. Safety (adverse events, laboratory values).

    Time frame: 5 years

Secondary outcomes

  1. Evaluation of gastrointestinal symptoms, histological parameters.

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2007
Study completion
2008
First posted
Dec 5, 2005
Registry last updated
May 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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