NCT01824199

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2013

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

3.7 years

First QC Date

March 27, 2013

Last Update Submit

October 9, 2017

Conditions

Esophagitis

Keywords

Esophagitis

Outcome Measures

Primary Outcomes (1)

  • The correlation specific to CYP2C19 genotype with gastric acid suppression by omeprazole.

    8 weeks

Secondary Outcomes (1)

  • To assess patients gastrointestinal symptoms, in patients with EoE by means of standard validated questionnaires

    30 days

Study Arms (1)

Omeprazole

EXPERIMENTAL

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.

Drug: Omeprazole

Interventions

OmeprazoleDRUG

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.

Also known as: Prilosec
Omeprazole

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Esophagitis

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritis

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • David Katzka, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 27, 2013

First Posted

April 4, 2013

Study Start

March 1, 2013

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

October 11, 2017

Record last verified: 2017-10

Locations

US(1)