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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
Information provided by (Responsible Party):
Alvine Pharmaceuticals Inc.

March 20, 2012
March 22, 2012
October 10, 2013
March 2012
September 2013   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01560169 on ClinicalTrials.gov Archive Site
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
Same as current
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Evaluation of Patient Reported Outcome Instruments in Celiac Disease Patients
Clinical Evaluation of Three Celiac Disease-Specific Patient Reported Outcome Instruments in Established and Newly Diagnosed Celiac Disease Patients
This is an evaluation of celiac-specific patient reported outcome instruments in celiac disease patients.
Not Provided
Time Perspective: Prospective
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Non-Probability Sample
Biopsy proven celiac disease patients
Celiac Disease
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  • Gluten challenge
    Gluten containing or gluten-free study food in established celiac disease patients
  • Observation
    Observation in newly diagnosed celiac disease patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
September 2013
September 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
Not Provided
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Alvine Pharmaceuticals Inc.
Alvine Pharmaceuticals Inc.
Not Provided
Study Chair: Daniel Adelman, MD Alvine Pharmaceuticals Inc.
Alvine Pharmaceuticals Inc.
October 2013