Predictors of Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis
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ClinicalTrials.gov Identifier: NCT01479231 |
Recruitment Status
:
Withdrawn
(Souces of funding have been terminated)
First Posted
: November 24, 2011
Last Update Posted
: April 19, 2012
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Sponsor:
Mayo Clinic
Information provided by (Responsible Party):
Jeffrey A Alexander, Mayo Clinic
Tracking Information | ||||
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First Submitted Date ICMJE | November 22, 2011 | |||
First Posted Date ICMJE | November 24, 2011 | |||
Last Update Posted Date | April 19, 2012 | |||
Study Start Date ICMJE | March 2012 | |||
Actual Primary Completion Date | March 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01479231 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Predictors of Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis | |||
Official Title ICMJE | Predictors of PPI Response in Eosinophilic Esophagitis | |||
Brief 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. Moreover, the investigators will determine the effect of GERD on the location of esophageal eosinophilia. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: dexlansoprazole
Dexlansoprazole 60 mg daily for 6 weeks
Other Name: Dexilant |
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Study Arms | Experimental: dexlansoprazole
Intervention: Drug: dexlansoprazole |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Withdrawn | |||
Actual Enrollment ICMJE |
0 | |||
Original Estimated Enrollment ICMJE |
60 | |||
Actual Study Completion Date | March 2012 | |||
Actual Primary Completion Date | March 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Patient population - adults with EoE recruited from Mayo Clinic Rochester, MN patient population |
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Sex/Gender |
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Ages | 18 Years to 80 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01479231 | |||
Other Study ID Numbers ICMJE | 11-003759 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Jeffrey A Alexander, Mayo Clinic | |||
Study Sponsor ICMJE | Mayo Clinic | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Mayo Clinic | |||
Verification Date | April 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |