A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Celiac Disease

In brief

A randomized, double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of Larazotide Acetate in the treatment of patients with celiac disease who have persistent symptoms despite being on a gluten-free diet.

Key facts

Study ID

NCT01396213

Run by

9 Meters Biopharma, Inc.

People needed

342

Starts

2011-11-07

Expected to finish

2013-08-20

Last updated by the study team

2017-09-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female adults with biopsy proven and serology-confirmed celiac disease on a gluten-free diet for at least 12 months
• measurable serology at screening
• CeD GSRS score of ≥ 2.0 prior to randomization
• experiencing symptoms (ie, diarrhea, abdominal pain, bloating, nausea, or stomachache)
• willing to maintain current diet gluten-free diet throughout the duration of the study.

You may not qualify if…

• refractory celiac disease or severe complications of celiac disease (eg, EATL, ulcerative jejunitis, perforation, etc.)
• chronic active GI disease other than celiac disease
• diabetes (Type 1 or 2) or other autoimmune disease that might interfere with the conduct of the study
• hemoglobin value < 8.5 g/dL

Where it is running

• Study site — Mesa, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Oceanside, California, United States
• Study site — Orange, California, United States
• Study site — San Francisco, California, United States
• Study site — Santa Monica, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Denver, Colorado, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Edgewater, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Summerfield, Florida, United States
• Study site — Marietta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Rockford, Illinois, United States
• Study site — West Des Moines, Iowa, United States
• Study site — Wichita, Kansas, United States
• Study site — Lexington, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Baltimore, Maryland, United States
• Study site — Hagerstown, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Chesterfield, Michigan, United States
• Study site — Wyoming, Michigan, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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