DRUG
Larazotide
Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules
Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms
Status
Terminated
Phase
Phase 3
Enrollment
307
Locations
160
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.
Full 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.
Interventions
Treatment arms and agents.
DRUG
Matching Placebo
enteric-coated beads in gelatin capsules
Timeline
From registration to results.
First posted
Jun 26, 2018
Study start
May 29, 2019
Primary completion
Jul 21, 2022
Study completion
Jul 21, 2022
Results posted
Not reported
Registry updated
Jul 26, 2022
Outcomes
What the study measures.
Primary outcomes
Proportion of subjects who are binary responders
Time frame · 12 weeks
Reduction in CeD PRO Abdominal Domain scores
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 locations
160 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
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
Research Site
Lancaster, California, United States
Research Site
Los Gatos, California, United States
Research Site
Northridge, California, United States
Research Site
Poway, California, United States
Research Site
Rialto, California, United States
Research Site
San Diego, California, United States
Research Site
San Diego, California, United States
Research Site
San Francisco, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Bridgeport, Connecticut, United States
Research Site
Bristol, Connecticut, United States
Research Site
Hamden, Connecticut, United States
Research Site
Stamford, Connecticut, United States
Research Site
Boynton Beach, Florida, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
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