Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms
A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of Persistent Symptoms in Patients With Celiac Disease on a GFD
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.
Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules
enteric-coated beads in gelatin capsules
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