EsophagitisEarly Phase 1NCT01824199
CYP2C19 Genotype Predictor of Gastric Acid Suppression
A Early Phase 1 study testing Omeprazole in people with Esophagitis, run by Mayo Clinic at 1 site in United States.
Trial summary
If CYP2C19 genotype can predict the efficacy of healing erosive esophagitis and gastric acid secretion in patients taking once a day omeprazole. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagitis
- What is being tested?
- Omeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Nov 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: CYP2C19 Genotype as a Predictor of Gastric Acid Suppression and Healing of Erosive Esophagitis
If CYP2C19 genotype can predict the efficacy of healing erosive esophagitis and gastric acid secretion in patients taking once a day omeprazole.
Read the 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
- Conditions
- Esophagitis
- Being tested
- Omeprazole
- Keywords
- Esophagitis
- Medical subject headings
- Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Also called Prilosec
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation specific to CYP2C19 genotype with gastric acid suppression by omeprazole.
Measured: 8 weeks
Secondary outcomes (1)
To assess patients gastrointestinal symptoms, in patients with EoE by means of standard validated questionnaires
trouble swallowing, heartburn, acid regurgitation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startMar 2013 (estimated)
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsophagitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David A. Katzka, Mayo Clinic
- Investigators
- David Katzka, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824199
- Sponsor's protocol ID
- 12-008053
- Status last verified
- Oct 2017
- First submitted
- 27 Mar 2013
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CYP2C19 Genotype as a Predictor of Gastric Acid Suppression and Healing of Erosive Esophagitis
- ClinicalTrials.gov ID
- NCT01824199
- Acronym / sponsor ID
- 12-008053
- Conditions
- Esophagitis
- Keywords
- Esophagitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2013 (estimated)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omeprazole | Experimental | Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmeprazoleAlso: PrilosecPatients 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. | Drug | Omeprazole |
Primary outcome
The correlation specific to CYP2C19 genotype with gastric acid suppression by omeprazole.
Time frame: 8 weeks
1 secondary outcome
To assess patients gastrointestinal symptoms, in patients with EoE by means of standard validated questionnaires
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Katzka, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Omeprazole in people with Esophagitis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation specific to CYP2C19 genotype with gastric acid suppression by omeprazole. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017.