Evaluation of Patient Reported Outcome Instruments in Celiac Disease Patients

Celiac Disease Clinical Trial

Official title:

Clinical Evaluation of Three Celiac Disease-Specific Patient Reported Outcome Instruments in Established and Newly Diagnosed Celiac Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01560169
• Other study ID #: ALV003-1121
• Status: Completed
• Phase: N/A
• First received: March 20, 2012
• Last updated: October 9, 2013
• Start date: March 2012
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: Alvine Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Celiac Disease

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
United States	University of Colorado, Denver	Aurora	Colorado
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	University of Chicago Celiac Disease Center	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of California, San Diego	La Jolla	California
United States	Columbia University	New York City	New York
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Kaiser Permanente Southern California, Allergy Department	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Alvine Pharmaceuticals Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety - incidence of adverse events	Safety will be evaluated by incidents of adverse events including clinical significant laboratory evaluations and serious adverse events	8 and 12 weeks	Yes