Safety Study of Larazotide Acetate to Treat Celiac Disease.

Completed · Phase 1 · Has a placebo group

Conditions studied: Celiac Disease

In brief

To demonstrate the safety, pharmacokinetics and efficacy of larazotide acetate in patients with controlled celiac disease on a gluten-free diet following a gluten challenge.

Key facts

Study ID

NCT00386165

Run by

9 Meters Biopharma, Inc.

People needed

21

Starts

2005-11-29

Expected to finish

2006-01-26

Last updated by the study team

2017-09-11

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must have been diagnosed with celiac disease by biopsy for ≥ 6 months (attending physician confirmation will be accepted in lieu of a biopsy report).
• Subject must be on a gluten-free diet for at least the past 6 months.

You may not qualify if…

• Subject has Anti-Tissue Transglutaminase (tTG) > 10 EU as measured by serology
• Subject intermittently consumes clinically significant quantities of non-steroidal anti-inflammatory agents ("NSAIDs") and proton-pump inhibitors, within the last 3 days prior to the treatment visit.

Where it is running

• Parexel — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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