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

This study has been completed.
Sponsor:
Information provided by:
Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:
NCT00261300
First received: December 2, 2005
Last updated: May 4, 2012
Last verified: December 2008
History of Changes

December 2, 2005
May 4, 2012
October 2000
September 2007   (final data collection date for primary outcome measure)
Safety (adverse events, laboratory values). [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Safety (adverse events, laboratory values).
Complete list of historical versions of study NCT00261300 on ClinicalTrials.gov Archive Site
Evaluation of gastrointestinal symptoms, histological parameters. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Evaluation of gastrointestinal symptoms, histological parameters.
Not Provided
Not Provided
 
Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708)
Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints

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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gastroesophageal Reflux Disease (GERD)
  • Peptic Ulcers
Drug: Pantoprazole
Long term Pantoprozole trial
Experimental: 1
Pantoprazole 40 mg
Intervention: Drug: Pantoprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
July 2008
September 2007   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00261300
BY1023/VMG-708
Not Provided
Nycomed
Takeda Global Research & Development Center, Inc.
Not Provided
Principal Investigator: Gorig Brunner, Prof. Dr. 30659 Hannover, Germany
Takeda Global Research & Development Center, Inc.
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP