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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00492960
Other study ID # CLIN1001-006
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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