Celiac Disease Clinical Trial
Official title:
A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of Persistent Symptoms in Patients With Celiac Disease on a GFD
| Verified date | August 2021 |
| Source | 9 Meters Biopharma, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.
| Status | Terminated |
| Enrollment | 307 |
| Est. completion date | July 21, 2022 |
| Est. primary completion date | July 21, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Male and female adults diagnosed with celiac disease (positive celiac serology plus confirmed biopsy) for at least 6 months - 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: - Refractory celiac disease or severe complications of celiac disease - Chronic active GI disease other than celiac disease |
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Albuquerque | New Mexico |
| United States | Research Site | Annapolis | Maryland |
| United States | Research Site | Arlington Heights | Illinois |
| United States | Research Site | Asheville | North Carolina |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Bellevue | Washington |
| United States | Research Site | Bellevue | Washington |
| United States | Research Site | Bellflower | California |
| United States | Research Site | Beverly Hills | California |
| United States | Research Site | Boise | Idaho |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Boynton Beach | Florida |
| United States | Research Site | Bridgeport | Connecticut |
| United States | Research Site | Bristol | Connecticut |
| United States | Research Site | Canoga Park | California |
| United States | Research Site | Catonsville | Maryland |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Chattanooga | Tennessee |
| United States | Research Site | Chesapeake | Virginia |
| United States | Research Site | Chesterfield | Michigan |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Clearwater | Florida |
| United States | Research Site | Cleveland | Ohio |
| United States | Research Site | Clive | Iowa |
| United States | Research Site | Columbia | Maryland |
| United States | Research Site | Columbus | Georgia |
| United States | Research Site | Columbus | Ohio |
| United States | Research Site | Columbus | Ohio |
| United States | Research Site | Concord | North Carolina |
| United States | Research Site | Corona | California |
| United States | Research Site | Crowley | Louisiana |
| United States | Research Site | Cypress | Texas |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Dayton | Ohio |
| United States | Research Site | Dayton | Ohio |
| United States | Research Site | DeSoto | Texas |
| United States | Research Site | Fairfax | Virginia |
| United States | Research Site | Fairview Heights | Illinois |
| United States | Research Site | Fall River | Massachusetts |
| United States | Research Site | Freehold | New Jersey |
| United States | Research Site | Gainesville | Virginia |
| United States | Research Site | Garden Grove | California |
| United States | Research Site | Garland | Texas |
| United States | Research Site | Great Neck | New York |
| United States | Research Site | Greenville | North Carolina |
| United States | Research Site | Hagerstown | Maryland |
| United States | Research Site | Hamden | Connecticut |
| United States | Research Site | Happy Valley | Oregon |
| United States | Research Site | Harlingen | Texas |
| United States | Research Site | Hershey | Pennsylvania |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Idaho Falls | Idaho |
| United States | Research Site | Inverness | Florida |
| United States | Research Site | Iowa City | Iowa |
| United States | Research Site | Jackson | Minnesota |
| United States | Research Site | Jefferson City | Missouri |
| United States | Research Site | Lafayette | Louisiana |
| United States | Research Site | Lakewood Ranch | Florida |
| United States | Research Site | Lancaster | California |
| United States | Research Site | Lansdowne Town Center | Virginia |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Lexington | Kentucky |
| United States | Research Site | Lexington | Kentucky |
| United States | Research Site | Lincoln | Rhode Island |
| United States | Research Site | Los Gatos | California |
| United States | Research Site | Louisville | Kentucky |
| United States | Research Site | Lynchburg | Virginia |
| United States | Research Site | Macon | Georgia |
| United States | Research Site | Maplewood | Minnesota |
| United States | Research Site | Marrero | Louisiana |
| United States | Research Site | McAllen | Texas |
| United States | Research Site | Medford | Oregon |
| United States | Research Site | Melrose Park | Illinois |
| United States | Research Site | Mentor | Ohio |
| United States | Research Site | Metairie | Louisiana |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Mineola | New York |
| United States | Research Site | Morton | Illinois |
| United States | Research Site | Mount Pleasant | South Carolina |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | New Orleans | Louisiana |
| United States | Research Site | New Orleans | Louisiana |
| United States | Research Site | New Windsor | New York |
| United States | Research Site | New York | New York |
| United States | Research Site | New York | New York |
| United States | Research Site | New York | New York |
| United States | Research Site | Norfolk | Virginia |
| United States | Research Site | Norman | Oklahoma |
| United States | Research Site | North Little Rock | Arkansas |
| United States | Research Site | Northridge | California |
| United States | Research Site | Ocean Township | New Jersey |
| United States | Research Site | Ogden | Utah |
| United States | Research Site | Ogden | Utah |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Omaha | Nebraska |
| United States | Research Site | Omaha | Nebraska |
| United States | Research Site | Orange Park | Florida |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Petal | Mississippi |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Poland | Ohio |
| United States | Research Site | Port Orange | Florida |
| United States | Research Site | Portsmouth | New Hampshire |
| United States | Research Site | Poughkeepsie | New York |
| United States | Research Site | Poway | California |
| United States | Research Site | Reno | Nevada |
| United States | Research Site | Rialto | California |
| United States | Research Site | Rochester | Minnesota |
| United States | Research Site | Rochester | Michigan |
| United States | Research Site | Saint George | Utah |
| United States | Research Site | Saint Louis | Missouri |
| United States | Research Site | Salisbury | North Carolina |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| United States | Research Site | San Diego | California |
| United States | Research Site | San Francisco | California |
| United States | Research Site | Sandy | Utah |
| United States | Research Site | Saraland | Alabama |
| United States | Research Site | Sayre | Pennsylvania |
| United States | Research Site | Scottsdale | Arizona |
| United States | Research Site | Scranton | Pennsylvania |
| United States | Research Site | Sioux Falls | South Dakota |
| United States | Research Site | Spokane | Washington |
| United States | Research Site | Spokane | Washington |
| United States | Research Site | Stamford | Connecticut |
| United States | Research Site | Stockbridge | Georgia |
| United States | Research Site | Stone Mountain | Georgia |
| United States | Research Site | Sugar Hill | Georgia |
| United States | Research Site | Sugar Land | Texas |
| United States | Research Site | Sugar Land | Texas |
| United States | Research Site | Tacoma | Washington |
| United States | Research Site | Topeka | Kansas |
| United States | Research Site | Tucson | Arizona |
| United States | Research Site | Tucson | Arizona |
| United States | Research Site | Tulsa | Oklahoma |
| United States | Research Site | Vancouver | Washington |
| United States | Research Site | Victoria | Texas |
| United States | Research Site | Walnut Creek | California |
| United States | Research Site | Warwick | Rhode Island |
| United States | Research Site | Wauwatosa | Wisconsin |
| United States | Research Site | West Columbia | South Carolina |
| United States | Research Site | West Des Moines | Iowa |
| United States | Research Site | Williamsville | New York |
| United States | Research Site | Winston-Salem | North Carolina |
| United States | Research Site | Wyoming | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| 9 Meters Biopharma, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of subjects who are binary responders | Reduction in CeD PRO Abdominal Domain scores | 12 weeks |
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