Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Celiac Disease

In brief

This study is designed to evaluate the efficacy of a single dose of larazotide acetate in preventing intestinal permeability changes induced by a 6-week gluten challenge in subjects with celiac disease

Key facts

Study ID

NCT00889473

Run by

9 Meters Biopharma, Inc.

People needed

42

Starts

2009-04-01

Expected to finish

2010-04-01

Last updated by the study team

2017-09-20

Who can join

Age: 18 and older, up to 72. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female adults with biopsy proven celiac disease on a gluten-free diet for at least the past 6 months
• Anti-Tissue Transglutaminase (anti-tTG) ≤ 10 EU.
• BMI between 18.5 and 38, inclusive.

You may not qualify if…

• Has chronic active GI disease other than celiac disease
• Has diabetes (Type 1 or Type 2).
• Unable to abstain from alcohol consumption or NSAID use for 48 hours prior to each intestinal permeability collection throughout the study.
• Has hemoglobin value below 8.5 g/dL

Where it is running

• Study Site — Orange, California, United States
• Study Site — Topeka, Kansas, United States
• Study Site — Lexington, Kentucky, United States
• Study Site — Hagerstown, Maryland, United States
• Study Site — Silver Spring, Maryland, United States
• Study Site — Chesterfield, Michigan, United States
• Study Site — Troy, Michigan, United States
• Study Site — Rochester, Minnesota, United States
• Study Site — New York, New York, United States
• Study Site — Oklahoma City, Oklahoma, United States
• Study Site — Paoli, Pennsylvania, United States
• Study Site — Philadelphia, Pennsylvania, United States
• Study Site — Pittsburgh, Pennsylvania, United States
• Study Site — Franklin, Tennessee, United States
• Study Site — Edmonton, Alberta, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.