Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects

Completed · Phase 2 · Has a placebo group

Conditions studied: Celiac Disease

In brief

This study was run to determine the safety, tolerance, and efficacy of multiple doses of larazotide acetate in subjects with celiac disease following a gluten challenge.

Key facts

Study ID

NCT00362856

Run by

9 Meters Biopharma, Inc.

People needed

80

Starts

2006-09-13

Expected to finish

2007-03-06

Last updated by the study team

2017-09-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have been diagnosed with celiac disease by biopsy for ≥ 6 months.
• Have a Anti-Tissue Transglutaminase (tTG) ≤ 10 EU as measured by serology.
• Must be on a gluten-free diet for at least the past 6 months.

You may not qualify if…

• Have any chronic active GI disease other than celiac disease (e.g., IBS, Crohn's, Colitis).
• Have diabetes (Type 1 or Type 2).
• Chronically consumes non-steroidal anti-inflammatory agents ("NSAIDs") or takes proton-pump inhibitors.
• Consuming oral corticosteroids or immune suppressants.

Where it is running

• Research Site — Scottsdale, Arizona, United States
• Study site — San Diego, California, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Rochester, Minnesota, United States
• Study site — Morristown, New Jersey, United States
• Study site — Bismarck, North Dakota, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Research Site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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