Evaluation of Patient Reported Outcome Instruments in Celiac Disease Patients
NCT ID: NCT01560169
Last Updated: 2013-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
110 participants
OBSERVATIONAL
2012-03-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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PROSPECTIVE
Study Groups
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Gluten challenge
Gluten containing or gluten-free study food in established celiac disease patients
No interventions assigned to this group
Observation
Observation in newly diagnosed celiac disease patients
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Adherence to a gluten-free diet (established patients only)
* TG2 negative (established patients only)
* TG2 positive (newly diagnosed patients only)
* Signed informed consent
Exclusion Criteria
* Significant laboratory abnormalities
* History of untreated or GI disease
* Positive pregnancy test
* Any medical condition which could adversely affect study participation
18 Years
70 Years
ALL
No
Sponsors
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Alvine Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Adelman, MD
Role: STUDY_CHAIR
Alvine Pharmaceuticals Inc.
Locations
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University of California, San Diego
La Jolla, California, United States
Kaiser Permanente Southern California, Allergy Department
San Diego, California, United States
University of Colorado, Denver
Aurora, Colorado, United States
University of Chicago Celiac Disease Center
Chicago, Illinois, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Columbia University
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Alberta
Edmonton, Alberta, Canada
Countries
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Other Identifiers
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ALV003-1121
Identifier Type: -
Identifier Source: org_study_id