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 Details — Status: Completed

Administrative data

• NCT number: NCT00492960
• Other study ID #: CLIN1001-006
• Status: Completed
• Phase: Phase 2
• First received: June 25, 2007
• Last updated: September 15, 2017
• Start date: August 2007
• Est. completion date: March 2009

Study information

• Verified date: September 2017
• Source: Innovate Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: March 2009
• Est. primary completion date: October 2008
• 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

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Drug:
• larazotide acetate
gelatin capsules
• placebo
gelatin capsules

Dietary Supplement:
• 900 mg gluten
gelatin capsules

Locations

Country	Name	City	State
Canada	Study Site	Calgary
Canada	Study Site	Edmonton	Alberta
Canada	Study Site	Kelowna	British Columbia
Canada	Study Site	Montreal
Canada	Study Site	Toronto
Canada	Study Site	Winnipeg
United States	Study Site	Asheville	North Carolina
United States	Study Site	Boston	Massachusetts
United States	Study Site	Chicago	Illinois
United States	Study Site	Cleveland	Ohio
United States	Study Site	Colorado Springs	Colorado
United States	Study Site	Hagerstown	Maryland
United States	Study Site	Houston	Texas
United States	Study Site	Lexington	Kentucky
United States	Study Site	New York	New York
United States	Study Site	Philadelphia	Pennsylvania
United States	Study Site	Pittsburgh	Pennsylvania
United States	Study Site	Plano	Texas
United States	Study Site	Richmond	Virginia
United States	Study Site	Rochester	Minnesota
United States	Study Site	Scottsdale	Arizona
United States	Study Site	Seattle	Washington
United States	Study Site	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Innovate Biopharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Kelly CP, Green PH, Murray JA, Dimarino A, Colatrella A, Leffler DA, Alexander T, Arsenescu R, Leon F, Jiang JG, Arterburn LA, Paterson BM, Fedorak RN; Larazotide Acetate Celiac Disease Study Group. Larazotide acetate in patients with coeliac disease unde — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge.	The primary efficacy endpoint was the Day 49 to Day 7 ratio of urinary LAMA ratios as a response to gluten	Following ingestion of a solution of lactulose and mannitol; lactulose and mannitol excretion was quantified and the LAMA ratio calculated from overnight urine specimens collected on Days 7, 21, 35, 49 and 56.
Secondary	Safety of a 6-week exposure to oral doses of larazotide acetate in celiac disease patients exposed to 900 mg gluten TID with meals	Safety endpoints assessed in this study were adverse events, vital signs, physical examination results, clinical laboratory test results, concomitant medication usage and ECG results	Up to 6 weeks
Secondary	To prospectively validate a composite, weighted index of celiac disease activity	Gastrointestinal symptoms were assessed by the GSRS patient self-assessment questionnaire	GSRS was completed weekly throughout the study.