DRUG
larazotide acetate
gelatin capsules
Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease
Status
Completed
Phase
Phase 2
Enrollment
171
Locations
23
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
DRUG
placebo
gelatin capsules
DIETARY_SUPPLEMENT
900 mg gluten
gelatin capsules
Timeline
From registration to results.
First posted
Jun 27, 2007
Study start
Aug 2007
Primary completion
Oct 2008
Study completion
Mar 2009
Results posted
Not reported
Registry updated
Sep 20, 2017
Outcomes
What the study measures.
Primary outcomes
Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge.
Time frame · 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.
The primary efficacy endpoint was the Day 49 to Day 7 ratio of urinary LAMA ratios as a response to gluten
Secondary outcomes
Safety of a 6-week exposure to oral doses of larazotide acetate in celiac disease patients exposed to 900 mg gluten TID with meals
Time frame · Up to 6 weeks
Safety endpoints assessed in this study were adverse events, vital signs, physical examination results, clinical laboratory test results, concomitant medication usage and ECG results
To prospectively validate a composite, weighted index of celiac disease activity
Time frame · GSRS was completed weekly throughout the study.
Gastrointestinal symptoms were assessed by the GSRS patient self-assessment questionnaire
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 72 Years
- Sex
- ALL
- Healthy volunteers
- No
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 locations
23 registered sites.
Canada · United States. Showing up to 24 locations stored in the fast local snapshot.
Study Site
Scottsdale, Arizona, United States
Study Site
Colorado Springs, Colorado, United States
Study Site
Chicago, Illinois, United States
Study Site
Lexington, Kentucky, United States
Study Site
Hagerstown, Maryland, United States
Study Site
Boston, Massachusetts, United States
Study Site
Troy, Michigan, United States
Study Site
Rochester, Minnesota, United States
Study Site
New York, New York, United States
Study Site
Asheville, North Carolina, United States
Study Site
Cleveland, Ohio, United States
Study Site
Philadelphia, Pennsylvania, United States
Study Site
Pittsburgh, Pennsylvania, United States
Study Site
Houston, Texas, United States
Study Site
Plano, Texas, United States
Study Site
Richmond, Virginia, United States
Study Site
Seattle, Washington, United States
Study Site
Edmonton, Alberta, Canada
Study Site
Kelowna, British Columbia, Canada
Study Site
Calgary, Canada
Study Site
Montreal, Canada
Study Site
Toronto, Canada
Study Site
Winnipeg, Canada
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