Clinical trial NCT00889473: Study of the Efficacy of Larazotide Acetate to Treat 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
gluten
Lead sponsor: 9 Meters Biopharma, Inc.
Sponsor class: INDUSTRY
First posted: 2009-04-29
Enrollment: 42
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
Primary purpose: TREATMENT

Brief 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

Detailed 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.

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: Response to gluten
timeFrame: 6 weeks
Secondary outcomes:
measure: Anti-transglutaminase
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Orange
country: United States
facility: Study Site
state: California
city: Topeka
country: United States
facility: Study Site
state: Kansas
city: Lexington
country: United States
facility: Study Site
state: Kentucky
city: Hagerstown
country: United States
facility: Study Site
state: Maryland
city: Silver Spring
country: United States
facility: Study Site
state: Maryland
city: Chesterfield
country: United States
facility: Study Site
state: Michigan
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: Oklahoma City
country: United States
facility: Study Site
state: Oklahoma
city: Paoli
country: United States
facility: Study Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Study Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Study Site
state: Pennsylvania
city: Franklin
country: United States
facility: Study Site
state: Tennessee
city: Edmonton
country: Canada
facility: Study Site
state: Alberta
Study officials:
affiliation: Alba Therapeutics Inc
name: Francisco Leon, MD, PhD
role: STUDY_DIRECTOR
References: