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 is currently recruiting participants.

Verified by Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK), February 2009

First Received: September 27, 2007 Last Updated: February 6, 2009 History of Changes

Sponsored by:	Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK)
Information provided by:	Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK)
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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment
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 Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK):

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 ]

Estimated Enrollment:	370
Study Start Date:	April 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

tablet, 20 vs 60 mg daily

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 oligatory
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 chronical diesease
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

Contacts

Contact: Matthias Schwab, Prof, MD	004971181013700	matthias.schwab@ikp-stuttgart.de
Contact: Ulrich Klotz, Prof, Dr. rer. nat.	004971181013702	ulrich.klotz@ikp-stuttgart.de

Locations

Germany, Baden-Württemberg
Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology	Recruiting
Stuttgart, Baden-Württemberg, Germany, 70376
Principal Investigator: Matthias Schwab, Prof, MD

Sponsors and Collaborators

Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK)

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:	Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) ( Matthias Schwab/Prof, MD )
Study ID Numbers:	IKP-219
Study First Received:	September 27, 2007
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00537732 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK):

gastro-oesophageal reflux disease

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal Disorder

Gastrointestinal Diseases
Omeprazole
Esophageal Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions

Esophageal Motility Disorders
Deglutition Disorders
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases

ClinicalTrials.gov processed this record on September 11, 2009