Evaluation of Patient Reported Outcome Instruments in Celiac Disease Patients

Completed

• Conditions: Celiac Disease

• Registration Number: NCT01560169
• Lead Sponsor: Alvine Pharmaceuticals Inc.

Brief Summary

This is an evaluation of celiac-specific patient reported outcome instruments in celiac disease patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-20
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-22
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-09
• Last Update Posted: 2013-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in symptoms using patient reported outcome instruments	8 and 12 weeks	Sensitivity of the patient reported outcome instruments to detect change over time in celiac disease symptoms with and without a gluten challenge

Secondary Outcome Measures

Name	Time	Method
Safety - incidence of adverse events	8 and 12 weeks	Safety will be evaluated by incidents of adverse events including clinical significant laboratory evaluations and serious adverse events

Trial Locations

Locations (10)

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 City, New York, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada