Clinical Trial: Evaluation of Patient Reported Outcome Instruments in Celiac Disease Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Clinical Evaluation of Three Celiac Disease-Specific Patient Reported Outcome Instruments in Established and Newly Diagnosed Celiac Disease Pa

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

Detailed Summary:
Sponsor: Alvine Pharmaceuticals Inc.

Current Primary Outcome: Change in symptoms using patient reported outcome instruments [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome: Safety - incidence of adverse events [ Time Frame: 8 and 12 weeks ]

Safety will be evaluated by incidents of adverse events including clinical significant laboratory evaluations and serious adverse events


Original Secondary Outcome: Same as current

Information By: Alvine Pharmaceuticals Inc.

Dates:
Date Received: March 20, 2012
Date Started: March 2012
Date Completion:
Last Updated: October 9, 2013
Last Verified: October 2013