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

This study has been terminated.
(recruitment problems)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00537732
First Posted: October 1, 2007
Last Update Posted: February 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Matthias Schwab, Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK)
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Matthias Schwab, 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 ]

Secondary Outcome Measures:
  • clinical healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole [ Time Frame: 4 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00537732


Locations
Germany
Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology
Stuttgart, Baden-Württemberg, Germany, 70376
Sponsors and Collaborators
Matthias Schwab
Investigators
Principal Investigator: Matthias Schwab, Prof, MD Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology
  More Information

Publications:
Responsible Party: Matthias Schwab, MD, Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK)
ClinicalTrials.gov Identifier: NCT00537732     History of Changes
Other Study ID Numbers: IKP-219
2006-004650-24 ( EudraCT Number )
First Submitted: September 27, 2007
First Posted: October 1, 2007
Last Update Posted: February 25, 2014
Last Verified: February 2014

Keywords provided by Matthias Schwab, Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK):
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
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action