Status:
COMPLETED
Safety Study of Larazotide Acetate to Treat Celiac Disease.
Lead Sponsor:
9 Meters Biopharma, Inc.
Conditions:
Celiac Disease
Eligibility:
All Genders
18-59 years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
CLIN1001-002 was a Phase 1b, randomized, double-blind, placebo controlled study to determine the safety, tolerance, pharmacokinetic and pharmacodynamic effects of single doses of larazotide acetate in...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 29 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2006
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00386165
Start Date
November 29 2005
End Date
January 26 2006
Last Update
September 11 2017
Active Locations (1)
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1
Parexel
Baltimore, Maryland, United States, 21225