Status:
COMPLETED
Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease
Lead Sponsor:
9 Meters Biopharma, Inc.
Conditions:
Celiac Disease
Eligibility:
All Genders
18-72 years
Phase:
PHASE2
Brief Summary
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 diseas...
Detailed Description
This study is an extension of Study CLIN1001-006 (NCT 00492960). This is a Phase IIb, randomized, double-blind, placebo-controlled, dose ranging, multicenter study to determine the safety, tolerance, ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
- Exclusion Criteria
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00889473
Start Date
April 1 2009
End Date
April 1 2010
Last Update
September 20 2017
Active Locations (15)
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1
Study Site
Orange, California, United States
2
Study Site
Topeka, Kansas, United States
3
Study Site
Lexington, Kentucky, United States
4
Study Site
Hagerstown, Maryland, United States