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Evaluation of Patient Reported Outcome Instruments in Celiac Disease Patients

This study is currently recruiting participants.
Verified December 2012 by Alvine Pharmaceuticals Inc.
Sponsor:
Information provided by (Responsible Party):
Alvine Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01560169
First received: March 20, 2012
Last updated: December 17, 2012
Last verified: December 2012
History of Changes
  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:

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

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


Estimated Enrollment: 120
Study Start Date: March 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560169

Contacts
Contact: Annette Marcantonio, BS, MBA 650-596-2435 amarcantonio@alvinepharma.com

Locations
United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92037
Contact: Allan M Asuncion, MAS, CCRC     858-349-6900     aasuncion@ucsd.edu    
Contact: Sharon Quigley     858-657-5147     sjquigley@ucsd.edu    
Principal Investigator: Sheila E Crowe, MD            
Kaiser Permanente Southern California, Allergy Department Recruiting
San Diego, California, United States, 92111
Contact: Terrie Long, RN     858-573-5405     terrie.l.long@kp.org    
Contact: Travis Macareag     858-573-5405     travis.m.macaraeg@kp.org    
Principal Investigator: Robert Zeiger, MD, PhD            
United States, Colorado
University of Colorado, Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Brittany Siller, BS     303-724-1862     brittany.siller@ucdenver.edu    
Principal Investigator: Stephen Freeman, MD            
United States, Illinois
University of Chicago Celiac Disease Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Rose Arrieta, RN     773-702-5382     rarrieta@medicine.bsd.uchicago.edu    
Principal Investigator: Carol Semrad, MD            
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Josh Hansen     617-667-8397     jhansen@bidmc.harvard.edu    
Principal Investigator: Daniel Leffler, MD, MS            
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Carol Van Dyke, RN     507-266-7842     vandyke.carol@mayo.edu    
Principal Investigator: Vandana Nehra, MD            
United States, New York
Columbia University Recruiting
New York City, New York, United States, 10032
Principal Investigator: Benjamin Lebwohl, MD            
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Chung-Jyi Tsai, MD     216-444-9954     tsaic@ccf.org    
Contact: Louise Kincade     216-445-0953     kincadl@ccf.org    
Principal Investigator: Chung-Jyi Tsai, MD            
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Angela Gordon, RN     215-955-7979     angela.gordon@jefferson.edu    
Contact: Cynthia Miller, RN     215-955-8108     cynthia.miller@jefferson.edu    
Principal Investigator: Anthony J DiMarino, Jr, MD            
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2X8
Contact: Sharon Appelman-Eszczuk     780-492-8602     sharon.appelman@ualberta.ca    
Principal Investigator: Richard Fedorak, MD            
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: December 17, 2012
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
Malabsorption Syndromes
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013