Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms
- Registration Number
- NCT03569007
- Lead Sponsor
- 9 Meters Biopharma, Inc.
- Brief Summary
To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 307
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Matching Placebo Matching placebo capsules TID Larazotide 0.25 mg Larazotide Larazotide 0.25 mg capsules TID Larazotide 0.50 mg Larazotide Larazotide 0.50 mg capsules TID
- Primary Outcome Measures
Name Time Method Proportion of subjects who are binary responders 12 weeks Reduction in CeD PRO Abdominal Domain scores
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇺🇸Wauwatosa, Wisconsin, United States