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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
307
Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules
enteric-coated beads in gelatin capsules
Proportion of subjects who are binary responders
Reduction in CeD PRO Abdominal Domain scores
Time frame: 12 weeks
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Research Site
Saraland, Alabama, United States
Research Site
Scottsdale, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
North Little Rock, Arkansas, United States
Research Site
Bellflower, California, United States
Research Site
Beverly Hills, California, United States
Research Site
Canoga Park, California, United States
Research Site
Corona, California, United States
Research Site
Garden Grove, California, United States
...and 150 more locations