Clinical Trial: Study of the Efficacy of AT1001 (Larazotide Acetate) to Treat Celiac Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase IIb, Randomized, Double-blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of AT-1001 in Celiac Disease Su

Brief Summary:

This study will look at one dose of AT1001 for efficacy and safety for the treatment of celiac disease.

The primary efficacy outcome is the rate of response to gluten.

Detailed Summary: This is an outpatient, randomized, double-blind multicenter study. Subjects will remain on their gluten-free diet throughout the duration of the trial. Study drug or drug placebo capsules will be administered TID 15 minutes before each meal (breakfast, lunch, and dinner). Gluten or gluten placebo capsules will be taken TID with each meal.
Sponsor: Alba Therapeutics

Current Primary Outcome: Response to gluten [ Time Frame: 6 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Anti-transglutaminase [ Time Frame: 6 weeks ]

Original Secondary Outcome: Same as current

Information By: Alba Therapeutics

Dates:
Date Received: April 27, 2009
Date Started: April 2009
Date Completion:
Last Updated: July 12, 2012
Last Verified: January 2010