Omeprazole and Reflux Disease - Improvement of Clinical O... | NCT00537732

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

NCT00537732

Sponsor

Matthias Schwab

Status

Terminated

Last Update Posted

Feb 25, 2014Estimated

Enrollment

68Actual

Phase

Phase 4

Conditions

Gastroesophageal Reflux

Interventions

omeprazole
omeprazole

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2006-004650-24	EudraCT Number

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

recruitment problems

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Sep 27, 2007

First Submission Date that Met QC Criteria

Sep 28, 2007

First Posted Date

Oct 1, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2014

Last Update Posted Date

Feb 25, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Matthias Schwab, MD, Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)Sponsor-Investigator

Lead Sponsor

Matthias SchwabOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

68Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group	Active Comparator	3 tablets, only 20 mg omeprazole, genotype independent	Drug: omeprazole
intervention group	Active Comparator	20 vs. 60 mg daily, genotype dependent	Drug: omeprazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
omeprazole	Drug	20 mg daily	control group
omeprazole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
endoscopic healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole (according to metabolic capacity of the patient)		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
clinical healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole		4 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthias Schwab, Prof, MD	Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology		Stuttgart	Baden-Wurttemberg	70376	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15245569	Background	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.

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

ID	Term
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
D009930	Organic Chemicals