Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms
NCT ID: NCT03569007
Last Updated: 2022-07-26
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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TERMINATED
PHASE3
307 participants
INTERVENTIONAL
2019-05-29
2022-07-21
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
TRIPLE
Study Groups
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Larazotide 0.25 mg
Larazotide 0.25 mg capsules TID
Larazotide
Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules
Larazotide 0.50 mg
Larazotide 0.50 mg capsules TID
Larazotide
Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules
Placebo
Matching placebo capsules TID
Matching Placebo
enteric-coated beads in gelatin capsules
Interventions
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Larazotide
Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules
Matching Placebo
enteric-coated beads in gelatin capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* On a gluten-free diet for at least 6 months
* Experiencing symptoms (ie, abdominal pain, abdominal cramping, bloating, gas, diarrhea, loose stool, or nausea)
* Willing to maintain current gluten-free diet throughout participation in the study
Exclusion Criteria
* Chronic active GI disease other than celiac disease
18 Years
ALL
No
Sponsors
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9 Meters Biopharma, Inc.
INDUSTRY
Responsible Party
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Locations
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Saraland, Alabama, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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North Little Rock, Arkansas, United States
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Bellflower, California, United States
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Beverly Hills, California, United States
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Canoga Park, California, United States
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Corona, California, United States
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Garden Grove, California, United States
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Lancaster, California, United States
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Los Gatos, California, United States
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Northridge, California, United States
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Poway, California, United States
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Rialto, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Walnut Creek, California, United States
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Bridgeport, Connecticut, United States
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Bristol, Connecticut, United States
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Hamden, Connecticut, United States
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Stamford, Connecticut, United States
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Boynton Beach, Florida, United States
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Clearwater, Florida, United States
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Inverness, Florida, United States
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Lakewood Rch, Florida, United States
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Miami, Florida, United States
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Orange Park, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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Port Orange, Florida, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Macon, Georgia, United States
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Stockbridge, Georgia, United States
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Stone Mountain, Georgia, United States
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Sugar Hill, Georgia, United States
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Boise, Idaho, United States
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Idaho Falls, Idaho, United States
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Arlington Heights, Illinois, United States
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Fairview Heights, Illinois, United States
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Melrose Park, Illinois, United States
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Morton, Illinois, United States
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Clive, Iowa, United States
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Iowa City, Iowa, United States
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West Des Moines, Iowa, United States
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Topeka, Kansas, United States
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Lexington, Kentucky, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Crowley, Louisiana, United States
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Lafayette, Louisiana, United States
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Marrero, Louisiana, United States
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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New Orleans, Louisiana, United States
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Annapolis, Maryland, United States
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Baltimore, Maryland, United States
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Catonsville, Maryland, United States
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Columbia, Maryland, United States
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Hagerstown, Maryland, United States
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Boston, Massachusetts, United States
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Fall River, Massachusetts, United States
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Chesterfield, Michigan, United States
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Rochester, Michigan, United States
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Wyoming, Michigan, United States
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Jackson, Minnesota, United States
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Maplewood, Minnesota, United States
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Rochester, Minnesota, United States
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Petal, Mississippi, United States
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Jefferson City, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
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Portsmouth, New Hampshire, United States
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Freehold, New Jersey, United States
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Ocean Township, New Jersey, United States
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Albuquerque, New Mexico, United States
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Great Neck, New York, United States
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Mineola, New York, United States
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New Windsor, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Poughkeepsie, New York, United States
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Williamsville, New York, United States
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Concord, North Carolina, United States
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Greenville, North Carolina, United States
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Salisbury, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Dayton, Ohio, United States
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Mentor, Ohio, United States
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Poland, Ohio, United States
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Norman, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Happy Valley, Oregon, United States
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Medford, Oregon, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Sayre, Pennsylvania, United States
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Scranton, Pennsylvania, United States
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Lincoln, Rhode Island, United States
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Warwick, Rhode Island, United States
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Mt. Pleasant, South Carolina, United States
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West Columbia, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Cypress, Texas, United States
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Dallas, Texas, United States
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DeSoto, Texas, United States
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Garland, Texas, United States
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Harlingen, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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McAllen, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Sugar Land, Texas, United States
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Sugar Land, Texas, United States
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Victoria, Texas, United States
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Ogden, Utah, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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Sandy City, Utah, United States
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St. George, Utah, United States
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Chesapeake, Virginia, United States
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Fairfax, Virginia, United States
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Gainesville, Virginia, United States
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Lansdowne Town Center, Virginia, United States
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Lynchburg, Virginia, United States
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Norfolk, Virginia, United States
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Bellevue, Washington, United States
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Bellevue, Washington, United States
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Spokane, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Vancouver, Washington, United States
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Wauwatosa, Wisconsin, United States
Countries
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Other Identifiers
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CeD-LA-3001
Identifier Type: -
Identifier Source: org_study_id
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