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

Gastroesophageal Reflux Clinical Trial

— GERD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00537732
• Other study ID #: IKP-219
• Secondary ID: 2006-004650-24
• Status: Terminated
• Phase: Phase 4
• First received: September 27, 2007
• Last updated: February 24, 2014
• Start date: April 2007
• Est. completion date: December 2010

Study information

• Verified date: February 2014
• Source: Robert Bosch Gesellschaft für Medizinische Forschung mbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Drug:
• omeprazole
20 mg daily
• omeprazole
20 vs. 60 mg daily, genotype dependent

Locations

Country	Name	City	State
Germany	Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology	Stuttgart	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Matthias Schwab

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endoscopic healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole (according to metabolic capacity of the patient)		4 weeks	Yes
Secondary	clinical healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole		4 weeks	Yes