Status:
COMPLETED
Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects
Lead Sponsor:
9 Meters Biopharma, Inc.
Conditions:
Celiac Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
CLIN1001-004 was a randomized, double-blind, placebo controlled, dose-ranging, 7-arm, multicenter study with a gluten challenge. The objects were multiple dose safety and tolerance; efficacy (intestin...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 13 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2007
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00362856
Start Date
September 13 2006
End Date
March 6 2007
Last Update
September 12 2017
Active Locations (9)
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1
Research Site
Scottsdale, Arizona, United States, 85259
2
San Diego, California, United States, 92123
3
Research Site
Boston, Massachusetts, United States, 02215
4
Research Site
Rochester, Minnesota, United States, 55905