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NCT00889473 Clinical Trial

Study of the Efficacy of Larazotide Acetate to Treat 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 Details — Status: Completed

Administrative data
NCT number NCT00889473
Other study ID # CLIN1001-006 Part B
Secondary ID
Status Completed
Phase Phase 2
First received April 27, 2009
Last updated September 15, 2017
Start date April 2009
Est. completion date April 2010

Study information
Verified date September 2017
Source Innovate Biopharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 disease

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, and efficacy of larazotide acetate in subjects with celiac disease during a gluten challenge. 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. Gluten or gluten placebo capsules will be taken TID with each meal.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date April 2010
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 72 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Larazotide acetate
gelatin capsule
• Placebo
gelatin capsule
Dietary Supplement:
• Gluten 900 mg
gelatin capsule

Locations
Country Name City State
Canada Study Site Edmonton Alberta
United States Study Site Chesterfield Michigan
United States Study Site Franklin Tennessee
United States Study Site Hagerstown Maryland
United States Study Site Lexington Kentucky
United States Study Site New York New York
United States Study Site Oklahoma City Oklahoma
United States Study Site Orange California
United States Study Site Paoli Pennsylvania
United States Study Site Philadelphia Pennsylvania
United States Study Site Pittsburgh Pennsylvania
United States Study Site Rochester Minnesota
United States Study Site Silver Spring Maryland
United States Study Site Topeka Kansas
United States Study Site Troy Michigan

Sponsors (1)
Lead Sponsor Collaborator
Innovate Biopharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Response to gluten 6 weeks
Secondary Anti-transglutaminase 6 weeks
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