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Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease

Celiac Disease Clinical Trial

Official title:
A Phase IIb, Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of Larazotide Acetate (AT-1001) in Celiac Disease Subjects During a Gluten Challenge

Clinical Trial Summary

This study was conducted to evaluate the efficacy of multiple doses of larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge in subjects with celiac disease.

Clinical Trial Description

This was a Phase IIb, randomized, double-blind, placebo-controlled, dose ranging, multicenter Study to determine the safety, tolerance, and efficacy of larazotide acetate in subjects with celiac disease during a gluten challenge. Subjects remained on their gluten-free diet throughout the duration of the trial. Study drug or drug placebo capsules were administered TID 15 minutes before each meal. Gluten or gluten placebo capsules will be taken TID with each meal. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00492960
Study type Interventional
Source Innovate Biopharmaceuticals
Contact
Status Completed
Phase Phase 2
Start date August 2007
Completion date March 2009
View Details
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