Evaluation of Patient Reported Outcome Instruments in Celiac Disease Patients
Clinical Evaluation of Three Celiac Disease-Specific Patient Reported Outcome Instruments in Established and Newly Diagnosed Celiac Disease Patients
1 other identifier
observational
110
2 countries
10
Brief Summary
This is an evaluation of celiac-specific patient reported outcome instruments in celiac disease patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2012
10 active sites
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, 2012
CompletedFirst Submitted
Initial submission to the registry
March 20, 2012
CompletedFirst Posted
Study publicly available on registry
March 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedOctober 10, 2013
October 1, 2013
1.5 years
March 20, 2012
October 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in symptoms using patient reported outcome instruments
Sensitivity of the patient reported outcome instruments to detect change over time in celiac disease symptoms with and without a gluten challenge
8 and 12 weeks
Secondary Outcomes (1)
Safety - incidence of adverse events
8 and 12 weeks
Study Arms (2)
Gluten challenge
Gluten containing or gluten-free study food in established celiac disease patients
Observation
Observation in newly diagnosed celiac disease patients
Eligibility Criteria
Biopsy proven celiac disease patients
You may qualify if:
- History of biopsy proven celiac disease
- Adherence to a gluten-free diet (established patients only)
- TG2 negative (established patients only)
- TG2 positive (newly diagnosed patients only)
- Signed informed consent
You may not qualify if:
- History of IgE-mediated reactions to gluten
- Significant laboratory abnormalities
- History of untreated or GI disease
- Positive pregnancy test
- Any medical condition which could adversely affect study participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
University of California, San Diego
La Jolla, California, 92037, United States
Kaiser Permanente Southern California, Allergy Department
San Diego, California, 92111, United States
University of Colorado, Denver
Aurora, Colorado, 80045, United States
University of Chicago Celiac Disease Center
Chicago, Illinois, 60637, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Columbia University
New York, New York, 10032, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
University of Alberta
Edmonton, Alberta, T6G 2X8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Daniel Adelman, MD
Alvine Pharmaceuticals Inc.
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2012
First Posted
March 22, 2012
Study Start
March 1, 2012
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
October 10, 2013
Record last verified: 2013-10