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Evaluation of Patient Reported Outcome Instruments in Celiac Disease Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01560169
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : October 10, 2013
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease
Celiac Disease

Study Design

Study Type : Observational
Actual Enrollment : 110 participants
Time Perspective: Prospective
Official Title: Clinical Evaluation of Three Celiac Disease-Specific Patient Reported Outcome Instruments in Established and Newly Diagnosed Celiac Disease Patients
Study Start Date : March 2012
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Gluten challenge
Gluten containing or gluten-free study food in established celiac disease patients
Observation
Observation in newly diagnosed celiac disease patients


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Biopsy proven celiac disease patients
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01560169


Locations
United States, California
University of California, San Diego
La Jolla, California, United States, 92037
Kaiser Permanente Southern California, Allergy Department
San Diego, California, United States, 92111
United States, Colorado
University of Colorado, Denver
Aurora, Colorado, United States, 80045
United States, Illinois
University of Chicago Celiac Disease Center
Chicago, Illinois, United States, 60637
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Columbia University
New York City, New York, United States, 10032
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2X8
Sponsors and Collaborators
Alvine Pharmaceuticals Inc.
Investigators
Study Chair: Daniel Adelman, MD Alvine Pharmaceuticals Inc.
More Information

Responsible Party: Alvine Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01560169     History of Changes
Other Study ID Numbers: ALV003-1121
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: October 10, 2013
Last Verified: October 2013

Keywords provided by Alvine Pharmaceuticals Inc.:
Celiac Disease
Coeliac Disease
Celiac Sprue
Keilakia Disease

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases