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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03569007
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Innovate Biopharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Celiac Disease
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Larazotide 0.25 mg

Larazotide 0.25 mg capsules TID

Active Comparator: Larazotide 0.50 mg

Larazotide 0.50 mg capsules TID

Placebo Comparator: Placebo

Matching placebo capsules TID

Interventions

Drug: - Larazotide

Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules

Drug: - Matching Placebo

enteric-coated beads in gelatin capsules

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Innovate Research Site, Saraland, Alabama

Status

Recruiting

Address

Innovate Research Site

Saraland, Alabama, 36571

Innovate Research Site, Tucson, Arizona

Status

Recruiting

Address

Innovate Research Site

Tucson, Arizona, 85712

Innovate Research Site, Tucson, Arizona

Status

Recruiting

Address

Innovate Research Site

Tucson, Arizona, 85745

Innovate Research Site, Bellflower, California

Status

Recruiting

Address

Innovate Research Site

Bellflower, California, 90706

Innovate Research Site, Beverly Hills, California

Status

Recruiting

Address

Innovate Research Site

Beverly Hills, California, 90211

Innovate Research Site, Canoga Park, California

Status

Recruiting

Address

Innovate Research Site

Canoga Park, California, 91303

Innovate Research Site, Garden Grove, California

Status

Recruiting

Address

Innovate Research Site

Garden Grove, California, 92845

Innovate Research Site, Lancaster, California

Status

Recruiting

Address

Innovate Research Site

Lancaster, California, 93534

Innovate Research Site, Northridge, California

Status

Recruiting

Address

Innovate Research Site

Northridge, California, 91324

Innovate Research Site, Poway, California

Status

Recruiting

Address

Innovate Research Site

Poway, California, 92064

Innovate Research Site, Rialto, California

Status

Recruiting

Address

Innovate Research Site

Rialto, California, 92377

Innovate Research Site, San Diego, California

Status

Recruiting

Address

Innovate Research Site

San Diego, California, 92013

Innovate Research Site, San Diego, California

Status

Recruiting

Address

Innovate Research Site

San Diego, California, 92103

Innovate Research Site, San Francisco, California

Status

Withdrawn

Address

Innovate Research Site

San Francisco, California, 94102

Innovate Research Site, Walnut Creek, California

Status

Recruiting

Address

Innovate Research Site

Walnut Creek, California, 94598

Innovate Research Site, Bridgeport, Connecticut

Status

Recruiting

Address

Innovate Research Site

Bridgeport, Connecticut, 06606

Innovate Research Site, Stamford, Connecticut

Status

Withdrawn

Address

Innovate Research Site

Stamford, Connecticut, 06905

Innovate Research Site, Clearwater, Florida

Status

Recruiting

Address

Innovate Research Site

Clearwater, Florida, 33756

Innovate Research Site, Inverness, Florida

Status

Recruiting

Address

Innovate Research Site

Inverness, Florida, 34452

Innovate Research Site, Lakewood Ranch, Florida

Status

Recruiting

Address

Innovate Research Site

Lakewood Ranch, Florida, 34211

Innovate Research Site, Atlanta, Georgia

Status

Recruiting

Address

Innovate Research Site

Atlanta, Georgia, 30328

Innovate Research Site, Columbus, Georgia

Status

Recruiting

Address

Innovate Research Site

Columbus, Georgia, 31904

Innovate Research Site, Stockbridge, Georgia

Status

Recruiting

Address

Innovate Research Site

Stockbridge, Georgia, 30281

Innovate Research Site, Sugar Hill, Georgia

Status

Recruiting

Address

Innovate Research Site

Sugar Hill, Georgia, 30518

Innovate Research Site, Idaho Falls, Idaho

Status

Recruiting

Address

Innovate Research Site

Idaho Falls, Idaho, 83404

Innovate Research Site, Arlington Heights, Illinois

Status

Recruiting

Address

Innovate Research Site

Arlington Heights, Illinois, 60005

Innovate Research Site, Melrose Park, Illinois

Status

Recruiting

Address

Innovate Research Site

Melrose Park, Illinois, 60160

Innovate Research Site, Morton, Illinois

Status

Recruiting

Address

Innovate Research Site

Morton, Illinois, 61550

Innovate Research Site, Clive, Iowa

Status

Recruiting

Address

Innovate Research Site

Clive, Iowa, 50325

Innovate Research Site, West Des Moines, Iowa

Status

Recruiting

Address

Innovate Research Site

West Des Moines, Iowa, 50266

Innovate Research Site, Topeka, Kansas

Status

Recruiting

Address

Innovate Research Site

Topeka, Kansas, 66606

Innovate Research Site, Lexington, Kentucky

Status

Recruiting

Address

Innovate Research Site

Lexington, Kentucky, 40509

Innovate Research Site, Crowley, Louisiana

Status

Recruiting

Address

Innovate Research Site

Crowley, Louisiana, 70526

Innovate Research Site, Metairie, Louisiana

Status

Recruiting

Address

Innovate Research Site

Metairie, Louisiana, 70006

Innovate Research Site, New Orleans, Louisiana

Status

Recruiting

Address

Innovate Research Site

New Orleans, Louisiana, 70115

Innovate Research Site, New Orleans, Louisiana

Status

Recruiting

Address

Innovate Research Site

New Orleans, Louisiana, 70125

Innovate Research Site, Baltimore, Maryland

Status

Recruiting

Address

Innovate Research Site

Baltimore, Maryland, 21208

Innovate Research Site, Catonsville, Maryland

Status

Recruiting

Address

Innovate Research Site

Catonsville, Maryland, 21228

Innovate Research Site, Columbia, Maryland

Status

Recruiting

Address

Innovate Research Site

Columbia, Maryland, 21045

Innovate Research Site, Fall River, Massachusetts

Status

Recruiting

Address

Innovate Research Site

Fall River, Massachusetts, 02723

Innovate Research Site, Chesterfield, Michigan

Status

Recruiting

Address

Innovate Research Site

Chesterfield, Michigan, 48047

Innovate Research Site, Rochester, Michigan

Status

Recruiting

Address

Innovate Research Site

Rochester, Michigan, 48307

Innovate Research Site, Wyoming, Michigan

Status

Recruiting

Address

Innovate Research Site

Wyoming, Michigan, 49519

Innovate Research Site, Maplewood, Minnesota

Status

Recruiting

Address

Innovate Research Site

Maplewood, Minnesota, 55117

Innovate Research Site, Petal, Mississippi

Status

Recruiting

Address

Innovate Research Site

Petal, Mississippi, 39465

Innovate Research Site, Jefferson City, Missouri

Status

Recruiting

Address

Innovate Research Site

Jefferson City, Missouri, 65109

Innovate Research Site, Saint Louis, Missouri

Status

Recruiting

Address

Innovate Research Site

Saint Louis, Missouri, 63141

Innovate Research Site, Omaha, Nebraska

Status

Recruiting

Address

Innovate Research Site

Omaha, Nebraska, 68114

Innovate Research Site, Omaha, Nebraska

Status

Recruiting

Address

Innovate Research Site

Omaha, Nebraska, 68134

Innovate Research Site, Las Vegas, Nevada

Status

Recruiting

Address

Innovate Research Site

Las Vegas, Nevada, 89106

Innovate Research Site, Las Vegas, Nevada

Status

Recruiting

Address

Innovate Research Site

Las Vegas, Nevada, 89109

Innovate Research Site, Las Vegas, Nevada

Status

Recruiting

Address

Innovate Research Site

Las Vegas, Nevada, 89119

Innovate Research Site, Las Vegas, Nevada

Status

Recruiting

Address

Innovate Research Site

Las Vegas, Nevada, 89128

Innovate Research Site, Portsmouth, New Hampshire

Status

Recruiting

Address

Innovate Research Site

Portsmouth, New Hampshire, 03801

Innovate Research Site, Albuquerque, New Mexico

Status

Recruiting

Address

Innovate Research Site

Albuquerque, New Mexico, 87102

Innovate Research Site, Great Neck, New York

Status

Recruiting

Address

Innovate Research Site

Great Neck, New York, 11023

Innovate Research Site, Mineola, New York

Status

Recruiting

Address

Innovate Research Site

Mineola, New York, 11501

Innovate Research Site, New Windsor, New York

Status

Recruiting

Address

Innovate Research Site

New Windsor, New York, 12553

Innovate Research Site, New York, New York

Status

Recruiting

Address

Innovate Research Site

New York, New York, 10016

Innovate Research Site, Poughkeepsie, New York

Status

Recruiting

Address

Innovate Research Site

Poughkeepsie, New York, 12601

Innovate Research Site, Williamsville, New York

Status

Recruiting

Address

Innovate Research Site

Williamsville, New York, 14221

Innovate Research Site, Asheville, North Carolina

Status

Recruiting

Address

Innovate Research Site

Asheville, North Carolina, 28801

Innovate Research Site, Charlotte, North Carolina

Status

Recruiting

Address

Innovate Research Site

Charlotte, North Carolina, 28207

Innovate Research Site, Concord, North Carolina

Status

Recruiting

Address

Innovate Research Site

Concord, North Carolina, 28025

Innovate Research Site, Greenville, North Carolina

Status

Recruiting

Address

Innovate Research Site

Greenville, North Carolina, 27834

Innovate Research Site, Salisbury, North Carolina

Status

Recruiting

Address

Innovate Research Site

Salisbury, North Carolina, 28144

Innovate Research Site, Winston-Salem, North Carolina

Status

Recruiting

Address

Innovate Research Site

Winston-Salem, North Carolina, 27103

Innovate Research Site, Cincinnati, Ohio

Status

Recruiting

Address

Innovate Research Site

Cincinnati, Ohio, 45219

Innovate Research Site, Cleveland, Ohio

Status

Recruiting

Address

Innovate Research Site

Cleveland, Ohio, 44122

Innovate Research Site, Columbus, Ohio

Status

Recruiting

Address

Innovate Research Site

Columbus, Ohio, 43214

Innovate Research Site, Dayton, Ohio

Status

Recruiting

Address

Innovate Research Site

Dayton, Ohio, 45415

Innovate Research Site, Dayton, Ohio

Status

Recruiting

Address

Innovate Research Site

Dayton, Ohio, 45419

Innovate Research Site, Mentor, Ohio

Status

Recruiting

Address

Innovate Research Site

Mentor, Ohio, 44060

Innovate Research Site, Poland, Ohio

Status

Recruiting

Address

Innovate Research Site

Poland, Ohio, 44514

Innovate Research Site, Norman, Oklahoma

Status

Recruiting

Address

Innovate Research Site

Norman, Oklahoma, 73071

Innovate Research Site, Tulsa, Oklahoma

Status

Recruiting

Address

Innovate Research Site

Tulsa, Oklahoma, 74104

Innovate Research Site, Philadelphia, Pennsylvania

Status

Recruiting

Address

Innovate Research Site

Philadelphia, Pennsylvania, 19107

Innovate Research Site, Lincoln, Rhode Island

Status

Recruiting

Address

Innovate Research Site

Lincoln, Rhode Island, 02865

Innovate Research Site, Warwick, Rhode Island

Status

Recruiting

Address

Innovate Research Site

Warwick, Rhode Island, 02886

Innovate Research Site, Mount Pleasant, South Carolina

Status

Recruiting

Address

Innovate Research Site

Mount Pleasant, South Carolina, 29464

Innovate Research Site, West Columbia, South Carolina

Status

Recruiting

Address

Innovate Research Site

West Columbia, South Carolina, 29169

Innovate Research Site, Sioux Falls, South Dakota

Status

Recruiting

Address

Innovate Research Site

Sioux Falls, South Dakota, 57108

Innovate Research Site, Chattanooga, Tennessee

Status

Recruiting

Address

Innovate Research Site

Chattanooga, Tennessee, 37421

Innovate Research Site, Austin, Texas

Status

Recruiting

Address

Innovate Research Site

Austin, Texas, 78704

Innovate Research Site, Austin, Texas

Status

Recruiting

Address

Innovate Research Site

Austin, Texas, 78726

Innovate Research Site, Austin, Texas

Status

Recruiting

Address

Innovate Research Site

Austin, Texas, 78745

Innovate Research Site, Cypress, Texas

Status

Recruiting

Address

Innovate Research Site

Cypress, Texas, 77429

Innovate Research Site, Dallas, Texas

Status

Recruiting

Address

Innovate Research Site

Dallas, Texas, 75224

Innovate Research Site, DeSoto, Texas

Status

Recruiting

Address

Innovate Research Site

DeSoto, Texas, 75115

Innovate Research Site, Harlingen, Texas

Status

Recruiting

Address

Innovate Research Site

Harlingen, Texas, 78550

Innovate Research Site, Houston, Texas

Status

Recruiting

Address

Innovate Research Site

Houston, Texas, 77025

Innovate Research Site, Houston, Texas

Status

Recruiting

Address

Innovate Research Site

Houston, Texas, 77058

Innovate Research Site, Houston, Texas

Status

Recruiting

Address

Innovate Research Site

Houston, Texas, 77084

Innovate Research Site, McAllen, Texas

Status

Recruiting

Address

Innovate Research Site

McAllen, Texas, 78503

Innovate Research Site, Sugar Land, Texas

Status

Recruiting

Address

Innovate Research Site

Sugar Land, Texas, 77476

Innovate Research Site, Sugar Land, Texas

Status

Recruiting

Address

Innovate Research Site

Sugar Land, Texas, 77479

Innovate Research Site, Victoria, Texas

Status

Recruiting

Address

Innovate Research Site

Victoria, Texas, 77904

Innovate Research Site, Ogden, Utah

Status

Recruiting

Address

Innovate Research Site

Ogden, Utah, 84405

Innovate Research Site, Saint George, Utah

Status

Recruiting

Address

Innovate Research Site

Saint George, Utah, 84790

Innovate Research Site, Fairfax, Virginia

Status

Recruiting

Address

Innovate Research Site

Fairfax, Virginia, 22031

Innovate Research Site, Gainesville, Virginia

Status

Recruiting

Address

Innovate Research Site

Gainesville, Virginia, 20155

Innovate Research Site, Lansdowne Town Center, Virginia

Status

Recruiting

Address

Innovate Research Site

Lansdowne Town Center, Virginia, 20176

Innovate Research Site, Lynchburg, Virginia

Status

Recruiting

Address

Innovate Research Site

Lynchburg, Virginia, 24502

Innovate Research Site, Norfolk, Virginia

Status

Recruiting

Address

Innovate Research Site

Norfolk, Virginia, 23507

Innovate Research Site, Bellevue, Washington

Status

Withdrawn

Address

Innovate Research Site

Bellevue, Washington, 98007

Innovate Research Site, Spokane, Washington

Status

Recruiting

Address

Innovate Research Site

Spokane, Washington, 99202

Innovate Research Site, Spokane, Washington

Status

Recruiting

Address

Innovate Research Site

Spokane, Washington, 99204

Innovate Research Site, Vancouver, Washington

Status

Recruiting

Address

Innovate Research Site

Vancouver, Washington, 98664

Innovate Research Site, Wauwatosa, Wisconsin

Status

Recruiting

Address

Innovate Research Site

Wauwatosa, Wisconsin, 53226

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