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

NCT00537732 | Terminated Phase 4 DMC

• 2 other identifiers: IKP-2192006-004650-24
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux

Keywords

gastro-oesophageal reflux disease

Outcome Measures

Primary Outcomes (1)

• 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 (1)

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

  4 weeks

Study Arms (2)

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

omeprazole DRUG

20 mg daily

control group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Matthias Schwab: lead

Study Sites (1)

Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology

Stuttgart, Baden-Wurttemberg, 70376, Germany

Location

Related Publications (1)

• 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.

  PMID: 15245569 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Matthias Schwab, Prof, MD

  Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 27, 2007
• First Posted: October 1, 2007
• Study Start: April 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 25, 2014

Record last verified: 2014-02

Locations

DE (1)