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Esophagitis | CYP2C19 Genotype Predictor of Gastric Acid Suppression

Esophagitis research study

What is the primary objective of this study?

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

Who is eligible to participate?

Inclusion criteria: - Age 18 or older - Have either mild-to-moderate Los Angeles (LA) Classification System grade B, moderately severe LA grade C, or severe LA grade D erosive reflux esophagitis - Or patients having a clinically indicated pH/impedance monitoring on proton pump inhibitor therapy for indications of gastroesophageal reflux disease. Exclusion criteria: - Neoplasm of the esophagus or stomach - Use of drugs that interfere with CYP2C19 metabolism Diazepam, phenytoin, amitriptyline, clomipramine, clopidogrel Cyclophosphamide, progesterone, fluoxetine, fluvoxamine, ketoconazole Lansoprazole, omeprazole, ticlopidine - Evidence of active H. pylori infection - Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy - Disorders which predispose to unreliable responses such as Schizophrenia, Alzheimer's disease or significant memory loss

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Esophagitis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:OmeprazolePatients with LA Grade B-D erosive esophagitis identified at the time of endoscopy will be prospectively recruited. 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

OmeprazolePatients 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.

Study Status

Withdrawn

Start Date: March 2013

Completed Date: November 2016

Phase: Early Phase 1

Type: Interventional

Design:

Primary Outcome: The correlation specific to CYP2C19 genotype with gastric acid suppression by omeprazole.

Secondary Outcome: To assess patients gastrointestinal symptoms, in patients with EoE by means of standard validated questionnaires

Study sponsors, principal investigator, and references

Principal Investigator: David Katzka, MD

Lead Sponsor: Mayo Clinic

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01824199

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