Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluation of Patient Reported Outcome Instruments in Celiac Disease Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alvine Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01560169
First received: March 20, 2012
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

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


Condition
Celiac Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Clinical Evaluation of Three Celiac Disease-Specific Patient Reported Outcome Instruments in Established and Newly Diagnosed Celiac Disease Patients

Resource links provided by NLM:


Further study details as provided by Alvine Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Change in symptoms using patient reported outcome instruments [ Time Frame: 8 and 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Safety - incidence of adverse events [ Time Frame: 8 and 12 weeks ] [ Designated as safety issue: Yes ]
    Safety will be evaluated by incidents of adverse events including clinical significant laboratory evaluations and serious adverse events


Enrollment: 110
Study Start Date: March 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Gluten challenge
Gluten containing or gluten-free study food in established celiac disease patients
Observation
Observation in newly diagnosed celiac disease patients

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Alvine Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01560169     History of Changes
Other Study ID Numbers: ALV003-1121
Study First Received: March 20, 2012
Last Updated: October 9, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 23, 2014