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:

Genetics Home Reference related topics: celiac disease

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 22, 2013

To Top