Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Celiac Disease

In brief

This study was conducted to evaluate the efficacy of multiple doses of larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge in subjects with celiac disease.

Key facts

Study ID

NCT00492960

Run by

9 Meters Biopharma, Inc.

People needed

171

Starts

2007-08-01

Expected to finish

2009-03-01

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 — Scottsdale, Arizona, United States
• Study Site — Colorado Springs, Colorado, United States
• Study Site — Chicago, Illinois, United States
• Study Site — Lexington, Kentucky, United States
• Study Site — Hagerstown, Maryland, United States
• Study Site — Boston, Massachusetts, United States
• Study Site — Troy, Michigan, United States
• Study Site — Rochester, Minnesota, United States
• Study Site — New York, New York, United States
• Study Site — Asheville, North Carolina, United States
• Study Site — Cleveland, Ohio, United States
• Study Site — Philadelphia, Pennsylvania, United States
• Study Site — Pittsburgh, Pennsylvania, United States
• Study Site — Houston, Texas, United States
• Study Site — Plano, Texas, United States
• Study Site — Richmond, Virginia, United States
• Study Site — Seattle, Washington, United States
• Study Site — Edmonton, Alberta, Canada
• Study Site — Kelowna, British Columbia, Canada
• Study Site — Calgary, Canada
• Study Site — Montreal, Canada
• Study Site — Toronto, Canada
• Study Site — Winnipeg, Canada

Full record on ClinicalTrials.gov

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