Trial terminated by Sponsor

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

Double-blind