Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Celiac Disease

In brief

To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.

Key facts

Study ID

NCT03569007

Run by

9 Meters Biopharma, Inc.

People needed

307

Starts

2019-05-29

Expected to finish

2022-07-21

Last updated by the study team

2022-07-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Refractory celiac disease or severe complications of celiac disease
• Chronic active GI disease other than celiac disease

Where it is running

• 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
• Research Site — Clearwater, Florida, United States
• Research Site — Saraland, Alabama, United States

Full record on ClinicalTrials.gov

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