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

This study has been terminated.
(recruitment problems)
Sponsor:
Information provided by (Responsible Party):
Matthias Schwab, Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK)
ClinicalTrials.gov Identifier:
NCT00537732
First received: September 27, 2007
Last updated: February 24, 2014
Last verified: February 2014
  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: 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:


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
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
Study First Received: September 27, 2007
Last Updated: February 24, 2014
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 April 17, 2014