Omeprazole and Reflux Disease - Improvement of Clinical Outcome by Genotype-adjusted Dosing - Full Text View

Omeprazole and Reflux Disease - Improvement of Clinical Outcome by Genotype-adjusted Dosing (GERD)

This study has been terminated.

( recruitment problems )

First Received on September 27, 2007. Last Updated on February 1, 2011 History of Changes

Sponsor:	Robert Bosch Gesellschaft für Medizinische Forschung mbH
Collaborator:	Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP), Stuttgart and University of Tuebingen
Information provided by:	Robert Bosch Gesellschaft für Medizinische Forschung mbH
ClinicalTrials.gov Identifier:	NCT00537732

Purpose

Patients with gastroesophageal reflux disease (GERD) are either treated for 4 weeks with a standard dose (20mg) of omeprazole, a drug of first choice, or by an individualized dosing (20 or 60mg/day) according how fast the patient can metabolize (eliminate) the drug. The individual elimination capacity is genetically controlled and therefore all patients will be genotyped prior to therapy.

Condition	Intervention	Phase
Gastroesophageal Reflux	Drug: omeprazole	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Omeprazole and Reflux Disease - Improvement of Clinical Outcome by Genotype-adjusted Dosing

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by Robert Bosch Gesellschaft für Medizinische Forschung mbH:

Primary Outcome Measures:

endoscopic healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole (according to metabolic capacity of the patient) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

clinical healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	68
Study Start Date:	April 2007
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: control group 3 tablets, only 20 mg omeprazole, genotype independent	Drug: omeprazole 20 mg daily
Active Comparator: intervention group 20 vs. 60 mg daily, genotype dependent	Drug: omeprazole 20 vs. 60 mg daily, genotype dependent

Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with GERD grade A and B (mild to moderate severe disease) diagnosed by routine endoscopy will be recruited in different clinical and ambulant centres of gastroenterology; written informed consent is obligatory
Range of Age: 20-70
BMI: 20-30

Exclusion Criteria:

Patients who are allergic to proton-pump inhibitors or show incompatibility
Patients who have lactase deficiency
Patients who have severe chronic disease
Patients who participated in another study during the last three months
Patients who are pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537732

Locations

Germany
Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology
Stuttgart, Baden-Württemberg, Germany, 70376

Sponsors and Collaborators

Robert Bosch Gesellschaft für Medizinische Forschung mbH

Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP), Stuttgart and University of Tuebingen

Investigators

Principal Investigator:

Matthias Schwab, Prof, MD

Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology

More Information

Publications:

Klotz U, Schwab M, Treiber G. CYP2C19 polymorphism and proton pump inhibitors. Basic Clin Pharmacol Toxicol. 2004 Jul;95(1):2-8. Review.

Responsible Party:	Matthias Schwab/Prof, MD, Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) and University of Tuebingen
ClinicalTrials.gov Identifier:	NCT00537732 History of Changes
Other Study ID Numbers:	IKP-219
Study First Received:	September 27, 2007
Last Updated:	February 1, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Robert Bosch Gesellschaft für Medizinische Forschung mbH:

gastro-oesophageal reflux disease

Additional relevant MeSH terms:

Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Omeprazole

Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012