Evaluation of Patient Reported Outcome Instruments in Celiac Disease Patients

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

Completed

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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alberta, Edmonton, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Alvine Pharmaceuticals Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Mar 22, 2012
Registry last updated: Oct 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed