Gastroesophageal Reflux DiseasePhase 1/2NCT01479231
Predictors of Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis
A Phase 1/2 study testing dexlansoprazole in people with Gastroesophageal Reflux Disease and Eosinophilic Esophagitis, run by Mayo Clinic.
Trial summary
The investigators will determine the prevalence of gastroesophageal reflux disease (GERD) in Eosinophilic Esophagitis (EoE) and importantly determine the predictors of response to Proton Pump Inhibitor (PPI) therapy in EoE. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastroesophageal Reflux Disease, Eosinophilic Esophagitis, Dysphagia
- What is being tested?
- dexlansoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Mar 2012
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age < 80 years of age
- 14 eosinophils / hpf on biopsies from esophagus
- Abnormal validated Mayo dysphagia questionnaire (MDQ-30) (question 2"yes", question 4 > "moderate" and question 7 > "once a week")
- Clinically performed EGD with > 14 eosinophils/hpf completed within last 3 months
Who cannot join
- Other cause of dysphagia identified at endoscopy (e.g. stricture, web, infection, ring, achalasia, esophageal neoplasm)
- Dilatation of esophagus at time of index endoscopy
- Treatment with topical steroid within 3 months of index endoscopy
- Treatment with PPI in last 30 days prior to index EGD
- Patient population - adults with EoE recruited from Mayo Clinic Rochester, MN patient population
About this study
Official title: Predictors of PPI Response in Eosinophilic Esophagitis
The investigators will determine the prevalence of gastroesophageal reflux disease (GERD) in Eosinophilic Esophagitis (EoE) and importantly determine the predictors of response to Proton Pump Inhibitor (PPI) therapy in EoE. Moreover, the investigators will determine the effect of GERD on the location of esophageal eosinophilia.
- Being tested
- dexlansoprazole
- Keywords
- GERD, Eosinophilic esophagitis, Proton pump inhibitor, dysphagia
- Medical subject headings
- Gastroesophageal Reflux, Eosinophilic Esophagitis, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexlansoprazoleDrug
Also called Dexilant
Dexlansoprazole 60 mg daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| dexlansoprazole | Experimental | Not described Receives: Drug: dexlansoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Gastroesophageal Reflux Disease
Prevalence of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis (EoE) Description: The definition of GERD is acid exposure time of >4.2% over 24 hour period, as measured by pH monitoring.
Measured: 24 hour
Secondary outcomes (4)
Heartburn/regurgitation
Heartburn/regurgitation (as measured by:) Mayo Dysphagia Questionnaire - 30 Day Validated 28 item instrument; 0 = no dysphagia, higher levels indicate greater dysphagia severity. Dysphagia. 2010 Sep;25(3):221-30 Measured by "units on a scale"
Measured: 30 day
Abnormal 24 hour acid exposure
Abnormal 24 hour acid exposure (as measured by pH monitoring) Description: A thin plastic catheter is passed through one nostril, down the back of the throat, and into the esophagus as the patient swallows. The tip of the catheter contains a sensor that senses acid. The catheter protruding from the nose is connected to a recorder that registers each reflux of acid. The catheter is in place for 24 hours, when is removed and the recorder is attached to a computer so that the data can be downloaded.
Measured: 24 hour
Ratio of distal/proximal mean esophageal eosinophil number
Ratio of distal/proximal mean esophageal eosinophil number (as measured by biopsies taken during esophagogastroduodenoscopy (EGD))
Measured: 6 weeks
Mean distal eosinophil number
Mean distal eosinophil number (as measured by biopsies taken during esophagogastroduodenoscopy (EGD) )
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startMar 2012
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: Souces of funding have been terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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
- Phase 1/2
- 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, Jeffrey A Alexander, Mayo Clinic
- Investigators
- Jeffrey A Alexander, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479231
- Sponsor's protocol ID
- 11-003759
- Status last verified
- Apr 2012
- First submitted
- 22 Nov 2011
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of PPI Response in Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT01479231
- Acronym / sponsor ID
- 11-003759
- Keywords
- GERD, Eosinophilic esophagitis, Proton pump inhibitor, dysphagia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Souces of funding have been terminated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 24 Nov 2011 (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.
The investigators will determine the prevalence of gastroesophageal reflux disease (GERD) in Eosinophilic Esophagitis (EoE) and importantly determine the predictors of response to Proton Pump Inhibitor (PPI) therapy in EoE. Moreover, the investigators will determine the effect of GERD on the location of esophageal eosinophilia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dexlansoprazole | Experimental | Drug: dexlansoprazole |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age < 80 years of age
- 14 eosinophils / hpf on biopsies from esophagus
Key exclusion criteria (5 listed)
- Other cause of dysphagia identified at endoscopy (e.g. stricture, web, infection, ring, achalasia, esophageal neoplasm)
- Dilatation of esophagus at time of index endoscopy
- Treatment with topical steroid within 3 months of index endoscopy
- Treatment with PPI in last 30 days prior to index EGD
- Patient population - adults with EoE recruited from Mayo Clinic Rochester, MN patient population
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 |
|---|---|---|
| dexlansoprazoleAlso: DexilantDexlansoprazole 60 mg daily for 6 weeks | Drug | dexlansoprazole |
Primary outcome
Prevalence of Gastroesophageal Reflux Disease
Time frame: 24 hour
Prevalence of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis (EoE) Description: The definition of GERD is acid exposure time of >4.2% over 24 hour period, as measured by pH monitoring.
4 secondary outcomes
Heartburn/regurgitation
Time frame: 30 day
Abnormal 24 hour acid exposure
Time frame: 24 hour
Ratio of distal/proximal mean esophageal eosinophil number
Time frame: 6 weeks
Mean distal eosinophil number
Time frame: 6 weeks
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 19 Apr 2012.
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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.
Jeffrey A Alexander, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing dexlansoprazole in people with Gastroesophageal Reflux Disease and Eosinophilic Esophagitis, run by Mayo Clinic.
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 4 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 19 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Prevalence of Gastroesophageal Reflux Disease (time frame: 24 hour). 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 19 Apr 2012.