A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease
NCT ID: NCT01396213
Last Updated: 2017-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
342 participants
INTERVENTIONAL
2011-11-07
2013-08-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Larazotide Acetate 0.5 mg
larazotide acetate 0.5 mg capsules TID
Larazotide Acetate
gelatin capsule
Larazotide Acetate 1 mg
larazotide acetate 1 mg capsules TID
Larazotide Acetate
gelatin capsule
Larazotide Acetate 2 mg
larazotide acetate 2 mg capsules TID
Larazotide Acetate
gelatin capsule
Placebo
placebo capsules TID
placebo
gelatin capsule
Interventions
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Larazotide Acetate
gelatin capsule
placebo
gelatin capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* measurable serology at screening
* CeD GSRS score of ≥ 2.0 prior to randomization
* experiencing symptoms (ie, diarrhea, abdominal pain, bloating, nausea, or stomachache)
* willing to maintain current diet gluten-free diet throughout the duration of the study.
Exclusion Criteria
* chronic active GI disease other than celiac disease
* diabetes (Type 1 or 2) or other autoimmune disease that might interfere with the conduct of the study
* hemoglobin value \< 8.5 g/dL
18 Years
75 Years
ALL
No
Sponsors
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Teva Pharmaceuticals USA
INDUSTRY
9 Meters Biopharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Henrik Rasmussen, MD, PhD
Role: STUDY_DIRECTOR
Sponsor GmbH
Locations
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Birmingham, Alabama, United States
Mesa, Arizona, United States
Tucson, Arizona, United States
Oceanside, California, United States
Orange, California, United States
San Francisco, California, United States
Santa Monica, California, United States
Walnut Creek, California, United States
Denver, Colorado, United States
Boynton Beach, Florida, United States
Edgewater, Florida, United States
Orlando, Florida, United States
Summerfield, Florida, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Rockford, Illinois, United States
West Des Moines, Iowa, United States
Wichita, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
Hagerstown, Maryland, United States
Boston, Massachusetts, United States
Chesterfield, Michigan, United States
Wyoming, Michigan, United States
Duluth, Minnesota, United States
Rochester, Minnesota, United States
Jackson, Mississippi, United States
St Louis, Missouri, United States
Missoula, Montana, United States
Las Vegas, Nevada, United States
Marlton, New Jersey, United States
Lake Success, New York, United States
New York, New York, United States
New York, New York, United States
Rochester, New York, United States
Cary, North Carolina, United States
Salisbury, North Carolina, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Mentor, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Bethlehem, Pennsylvania, United States
Perkasie, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Warwick, Rhode Island, United States
Chattanooga, Tennessee, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
St. George, Utah, United States
Alexandria, Virginia, United States
Charlottesville, Virginia, United States
Seattle, Washington, United States
Edmonton, Alberta, Canada
Abbotsford, British Columbia, Canada
Kelowna, British Columbia, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Hamilton, Ontario, Canada
Countries
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References
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Leffler DA, Kelly CP, Green PH, Fedorak RN, DiMarino A, Perrow W, Rasmussen H, Wang C, Bercik P, Bachir NM, Murray JA. Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial. Gastroenterology. 2015 Jun;148(7):1311-9.e6. doi: 10.1053/j.gastro.2015.02.008. Epub 2015 Feb 13.
Other Identifiers
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Clin1001-012
Identifier Type: -
Identifier Source: org_study_id