CYP2C19 Genotype Predictor of Gastric Acid Suppression

Early Phase 1

Withdrawn

• Conditions: Esophagitis
• Interventions: Drug: Omeprazole

• Registration Number: NCT01824199
• Lead Sponsor: Mayo Clinic

Brief Summary

If CYP2C19 genotype can predict the efficacy of healing erosive esophagitis and gastric acid secretion in patients taking once a day omeprazole.

Detailed Description

Proton pump inhibitors are metabolized through the CYP2C19 hepatic enzyme system. Several variant genotypes of this enzyme exist which may lead to decreased, normal or increased metabolism of the proton pump inhibitor. With alteration of metabolism, the degree of gastric acid suppression achieved and efficacy in treating reflux could be affected. For example, Asian populations who have low activity of CYP2C19, commonly need lower doses of proton pump inhibitors to manage gastroesophageal reflux because of more sustained blood levels and availability of the drug. Theoretically, those patients who are rapid metabolizers would receive less effective treatment with proton pump inhibitors

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-27
• Study First Submitted QC: 2013-04-01
• Study First Posted: 2013-04-04
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-09
• Last Update Posted: 2017-10-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Omeprazole	Omeprazole	Patients will undergo whole blood testing for CYP2C19 genotype and will be started on omeprazole 40 mg once daily in the morning 30 minutes before breakfast. The Mayo Dysphasia Questionnaire 30 day (MDQ-30day) will be used during the study. At the end of 8 weeks, patients will undergo dual probe pH/impedance testing on therapy and a clinically indicated endoscopy to rule out Barrett's esophagus and assess healing. CYP2C19 genotyping will be performed in the Mayo laboratory.

Primary Outcome Measures

Name	Time	Method
The correlation specific to CYP2C19 genotype with gastric acid suppression by omeprazole.	8 weeks

Secondary Outcome Measures

Name	Time	Method
To assess patients gastrointestinal symptoms, in patients with EoE by means of standard validated questionnaires	30 days	trouble swallowing, heartburn, acid regurgitation

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States