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

March 20, 2012
October 9, 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 ] [ 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
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 ] [ Designated as safety issue: Yes ]
Safety will be evaluated by incidents of adverse events including clinical significant laboratory evaluations and serious adverse events
Same as current
Not Provided
Not Provided
 
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
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Biopsy proven celiac disease patients

Celiac Disease
Not Provided
  • 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.
 
Completed
110
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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01560169
ALV003-1121
No
Alvine Pharmaceuticals Inc.
Alvine Pharmaceuticals Inc.
Not Provided
Study Chair: Daniel Adelman, MD Alvine Pharmaceuticals Inc.
Alvine Pharmaceuticals Inc.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP