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

Primary Purpose

Gastroesophageal Reflux

Status

Terminated

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

omeprazole

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring gastro-oesophageal reflux disease

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

control group

intervention group

Arm Description

3 tablets, only 20 mg omeprazole, genotype independent

20 vs. 60 mg daily, genotype dependent

Outcomes

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)

Secondary Outcome Measures

clinical healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole

Full Information

NCT ID

NCT00537732

First Posted

September 27, 2007

Last Updated

February 24, 2014

Sponsor

Matthias Schwab

1. Study Identification

Unique Protocol Identification Number

NCT00537732

Brief Title

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

Acronym

GERD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Terminated

Why Stopped

recruitment problems

Study Start Date

April 2007 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Matthias Schwab

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Reflux

Keywords

gastro-oesophageal reflux disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control group

Arm Type

Active Comparator

Arm Description

3 tablets, only 20 mg omeprazole, genotype independent

Arm Title

intervention group

Arm Type

Active Comparator

Arm Description

20 vs. 60 mg daily, genotype dependent

Intervention Type

Drug

Intervention Name(s)

omeprazole

Intervention Description

20 mg daily

Intervention Type

Drug

Intervention Name(s)

omeprazole

Intervention Description

20 vs. 60 mg daily, genotype dependent

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

clinical healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthias Schwab, Prof, MD

Organizational Affiliation

Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology

City

Stuttgart

State/Province

Baden-Württemberg

ZIP/Postal Code

70376

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

15245569

Citation

Klotz U, Schwab M, Treiber G. CYP2C19 polymorphism and proton pump inhibitors. Basic Clin Pharmacol Toxicol. 2004 Jul;95(1):2-8. doi: 10.1111/j.1600-0773.2004.pto950102.x.

Results Reference

background

Learn more about this trial

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

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