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Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03569007
Recruitment Status : Recruiting
First Posted : June 26, 2018
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
9 Meters Biopharma, Inc.

Study Description
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Brief Summary:
To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.

Condition or disease Intervention/treatment Phase
Celiac Disease Drug: Larazotide Drug: Matching Placebo Phase 3

Detailed Description:
This is a phase 3, randomized, double-blind, placebo-controlled, multicenter, outpatient study to evaluate the efficacy and safety of larazotide acetate for the relief of persistent symptoms in adult patients with celiac disease on a gluten free diet.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
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
Actual Study Start Date : May 29, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Larazotide 0.25 mg
Larazotide 0.25 mg capsules TID
 Drug: Larazotide
Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules
Other Name: INN-202
Active Comparator: Larazotide 0.50 mg
Larazotide 0.50 mg capsules TID
 Drug: Larazotide
Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules
Other Name: INN-202
Placebo Comparator: Placebo
Matching placebo capsules TID
 Drug: Matching Placebo
enteric-coated beads in gelatin capsules
Other Name: placebo


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects who are binary responders [ Time Frame: 12 weeks ]
    Reduction in CeD PRO Abdominal Domain scores


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03569007


Contacts
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Contact: Anh Thu Nguyen 919-275-1933 joinstudy@9meters.com

Locations
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United States, Alabama
Research Site Recruiting
Saraland, Alabama, United States, 36571
United States, Arizona
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Tucson, Arizona, United States, 85712
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Tucson, Arizona, United States, 85745
United States, California
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Bellflower, California, United States, 90706
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Beverly Hills, California, United States, 90211
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Canoga Park, California, United States, 91303
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Garden Grove, California, United States, 92845
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Lancaster, California, United States, 93534
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Northridge, California, United States, 91324
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Poway, California, United States, 92064
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Rialto, California, United States, 92377
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San Diego, California, United States, 92013
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San Diego, California, United States, 92103
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San Francisco, California, United States, 94102
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Walnut Creek, California, United States, 94598
United States, Connecticut
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Bridgeport, Connecticut, United States, 06606
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Stamford, Connecticut, United States, 06905
United States, Florida
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Clearwater, Florida, United States, 33756
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Inverness, Florida, United States, 34452
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Lakewood Ranch, Florida, United States, 34211
United States, Georgia
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Atlanta, Georgia, United States, 30328
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Columbus, Georgia, United States, 31904
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Stockbridge, Georgia, United States, 30281
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Sugar Hill, Georgia, United States, 30518
United States, Idaho
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Idaho Falls, Idaho, United States, 83404
United States, Illinois
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Arlington Heights, Illinois, United States, 60005
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Melrose Park, Illinois, United States, 60160
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Morton, Illinois, United States, 61550
United States, Iowa
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Clive, Iowa, United States, 50325
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West Des Moines, Iowa, United States, 50266
United States, Kansas
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Topeka, Kansas, United States, 66606
United States, Kentucky
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Lexington, Kentucky, United States, 40509
United States, Louisiana
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Crowley, Louisiana, United States, 70526
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Metairie, Louisiana, United States, 70006
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New Orleans, Louisiana, United States, 70115
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New Orleans, Louisiana, United States, 70125
United States, Maryland
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Baltimore, Maryland, United States, 21208
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Catonsville, Maryland, United States, 21228
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Columbia, Maryland, United States, 21045
United States, Massachusetts
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Fall River, Massachusetts, United States, 02723
United States, Michigan
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Chesterfield, Michigan, United States, 48047
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Rochester, Michigan, United States, 48307
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Wyoming, Michigan, United States, 49519
United States, Minnesota
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Maplewood, Minnesota, United States, 55117
United States, Mississippi
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Petal, Mississippi, United States, 39465
United States, Missouri
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Jefferson City, Missouri, United States, 65109
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Saint Louis, Missouri, United States, 63141
United States, Nebraska
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Omaha, Nebraska, United States, 68114
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Omaha, Nebraska, United States, 68134
United States, Nevada
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Las Vegas, Nevada, United States, 89106
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Las Vegas, Nevada, United States, 89109
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Las Vegas, Nevada, United States, 89119
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Las Vegas, Nevada, United States, 89128
United States, New Hampshire
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Portsmouth, New Hampshire, United States, 03801
United States, New Mexico
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Albuquerque, New Mexico, United States, 87102
United States, New York
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Great Neck, New York, United States, 11023
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Mineola, New York, United States, 11501
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New Windsor, New York, United States, 12553
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New York, New York, United States, 10016
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Poughkeepsie, New York, United States, 12601
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Williamsville, New York, United States, 14221
United States, North Carolina
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Asheville, North Carolina, United States, 28801
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Charlotte, North Carolina, United States, 28207
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Concord, North Carolina, United States, 28025
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Greenville, North Carolina, United States, 27834
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Salisbury, North Carolina, United States, 28144
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Winston-Salem, North Carolina, United States, 27103
United States, Ohio
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Cincinnati, Ohio, United States, 45219
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Cleveland, Ohio, United States, 44122
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Columbus, Ohio, United States, 43214
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Dayton, Ohio, United States, 45415
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Dayton, Ohio, United States, 45419
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Mentor, Ohio, United States, 44060
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Poland, Ohio, United States, 44514
United States, Oklahoma
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Norman, Oklahoma, United States, 73071
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Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
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Lincoln, Rhode Island, United States, 02865
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Warwick, Rhode Island, United States, 02886
United States, South Carolina
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Mount Pleasant, South Carolina, United States, 29464
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West Columbia, South Carolina, United States, 29169
United States, South Dakota
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Sioux Falls, South Dakota, United States, 57108
United States, Tennessee
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Chattanooga, Tennessee, United States, 37421
United States, Texas
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Austin, Texas, United States, 78704
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Austin, Texas, United States, 78726
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Austin, Texas, United States, 78745
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Cypress, Texas, United States, 77429
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Dallas, Texas, United States, 75224
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DeSoto, Texas, United States, 75115
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Harlingen, Texas, United States, 78550
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Houston, Texas, United States, 77025
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Houston, Texas, United States, 77058
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Houston, Texas, United States, 77084
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McAllen, Texas, United States, 78503
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Sugar Land, Texas, United States, 77476
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Sugar Land, Texas, United States, 77479
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Victoria, Texas, United States, 77904
United States, Utah
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Ogden, Utah, United States, 84405
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Saint George, Utah, United States, 84790
United States, Virginia
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Fairfax, Virginia, United States, 22031
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Gainesville, Virginia, United States, 20155
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Lansdowne Town Center, Virginia, United States, 20176
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Lynchburg, Virginia, United States, 24502
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Norfolk, Virginia, United States, 23507
United States, Washington
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Bellevue, Washington, United States, 98007
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Spokane, Washington, United States, 99202
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Spokane, Washington, United States, 99204
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Vancouver, Washington, United States, 98664
United States, Wisconsin
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Wauwatosa, Wisconsin, United States, 53226
Sponsors and Collaborators
9 Meters Biopharma, Inc.
More Information
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Additional Information:

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Responsible Party: 9 Meters Biopharma, Inc.
ClinicalTrials.gov Identifier: NCT03569007    
Other Study ID Numbers: CeD-LA-3001
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases