CYP2C19 Genotype Predictor of Gastric Acid Suppression

Esophagitis Clinical Trial

Official title:

CYP2C19 Genotype as a Predictor of Gastric Acid Suppression and Healing of Erosive Esophagitis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01824199
• Other study ID #: 12-008053
• Status: Withdrawn
• Phase: Early Phase 1
• First received: March 27, 2013
• Last updated: October 9, 2017
• Start date: March 2013
• Est. completion date: November 2016

Study information

• Verified date: October 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophagitis

Intervention

Drug:
• Omeprazole
Patients 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The correlation specific to CYP2C19 genotype with gastric acid suppression by omeprazole.		8 weeks
Secondary	To assess patients gastrointestinal symptoms, in patients with EoE by means of standard validated questionnaires	trouble swallowing, heartburn, acid regurgitation	30 days