CYP2C19 Genotype Predictor of Gastric Acid Suppression
This trial is active, not recruiting.
|Start date||March 2013|
|End date||December 2016|
|Trial size||100 participants|
|Trial identifier||NCT01824199, 12-008053|
If CYP2C19 genotype can predict the efficacy of healing erosive esophagitis and gastric acid secretion in patients taking once a day omeprazole.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
The correlation specific to CYP2C19 genotype with gastric acid suppression by omeprazole.
time frame: 8 weeks
To assess patients gastrointestinal symptoms, in patients with EoE by means of standard validated questionnaires
time frame: 30 days
Male or female participants at least 18 years old.
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
|Official title||CYP2C19 Genotype as a Predictor of Gastric Acid Suppression and Healing of Erosive Esophagitis|
|Principal investigator||David Katzka, MD|
|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|
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