Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms
Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms
To assess the efficacy and safety of larazotide acetate versus placebo for the relief of
 persistent symptoms in adult celiac disease patients.
This is a phase 3, randomized, double-blind, placebo-controlled, multicenter, outpatient
 study to evaluate the efficacy and safety of larazotide acetate for the relief of persistent
 symptoms in adult patients with celiac disease on a gluten free diet.
Inclusion Criteria:

 -  Male and female adults diagnosed with celiac disease (positive celiac serology plus
 confirmed biopsy) for at least 6 months

 -  On a gluten-free diet for at least 6 months

 -  Experiencing symptoms (ie, abdominal pain, abdominal cramping, bloating, gas,
 diarrhea, loose stool, or nausea)

 -  Willing to maintain current gluten-free diet throughout participation in the study

 Exclusion Criteria:

 -  Refractory celiac disease or severe complications of celiac disease

 -  Chronic active GI disease other than celiac disease