Clinical trial NCT00492960: Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Celiac Disease
Keywords: larazotide acetate
Lead sponsor: 9 Meters Biopharma, Inc.
Sponsor class: INDUSTRY
First posted: 2007-06-27
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo Controlled, dose ranging, multicenter Study
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge.
timeFrame: 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 outcomes:
measure: Safety of a 6-week exposure to oral doses of larazotide acetate in celiac disease patients exposed to 900 mg gluten TID with meals
timeFrame: Up to 6 weeks
measure: To prospectively validate a composite, weighted index of celiac disease activity
timeFrame: GSRS was completed weekly throughout the study.
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Study Site
state: Arizona
city: Colorado Springs
country: United States
facility: Study Site
state: Colorado
city: Chicago
country: United States
facility: Study Site
state: Illinois
city: Lexington
country: United States
facility: Study Site
state: Kentucky
city: Hagerstown
country: United States
facility: Study Site
state: Maryland
city: Boston
country: United States
facility: Study Site
state: Massachusetts
city: Troy
country: United States
facility: Study Site
state: Michigan
city: Rochester
country: United States
facility: Study Site
state: Minnesota
city: New York
country: United States
facility: Study Site
state: New York
city: Asheville
country: United States
facility: Study Site
state: North Carolina
city: Cleveland
country: United States
facility: Study Site
state: Ohio
city: Philadelphia
country: United States
facility: Study Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Study Site
state: Pennsylvania
city: Houston
country: United States
facility: Study Site
state: Texas
city: Plano
country: United States
facility: Study Site
state: Texas
city: Richmond
country: United States
facility: Study Site
state: Virginia
city: Seattle
country: United States
facility: Study Site
state: Washington
city: Edmonton
country: Canada
facility: Study Site
state: Alberta
city: Kelowna
country: Canada
facility: Study Site
state: British Columbia
city: Calgary
country: Canada
facility: Study Site
city: Montreal
country: Canada
facility: Study Site
city: Toronto
country: Canada
facility: Study Site
city: Winnipeg
country: Canada
facility: Study Site
Study officials:
affiliation: Alba Therapeutics Corp
name: Francisco Leon, MD, Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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 undergoing a gluten challenge: a randomised placebo-controlled study. Aliment Pharmacol Ther. 2013 Jan;37(2):252-62. doi: 10.1111/apt.12147. Epub 2012 Nov 19.