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.

9 Meters Biopharma, Inc.
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.

Research Site, Saraland, Alabama

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Withdrawn

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Saraland, Alabama, 36571

Research Site, Tucson, Arizona

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Recruiting

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Tucson, Arizona, 85712

Research Site, Tucson, Arizona

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Tucson, Arizona, 85745

Research Site, North Little Rock, Arkansas

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North Little Rock, Arkansas, 72117

Research Site, Bellflower, California

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Bellflower, California, 90706

Research Site, Beverly Hills, California

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Beverly Hills, California, 90211

Research Site, Canoga Park, California

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Canoga Park, California, 91303

Research Site, Corona, California

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Corona, California, 92879

Research Site, Garden Grove, California

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Garden Grove, California, 92845

Research Site, Lancaster, California

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Lancaster, California, 93534

Research Site, Northridge, California

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Northridge, California, 91324

Research Site, Poway, California

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Poway, California, 92064

Research Site, Rialto, California

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Rialto, California, 92377

Research Site, San Diego, California

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San Diego, California, 92013

Research Site, San Diego, California

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San Diego, California, 92103

Research Site, San Francisco, California

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San Francisco, California, 94102

Research Site, Walnut Creek, California

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Walnut Creek, California, 94598

Research Site, Bridgeport, Connecticut

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Research Site

Bridgeport, Connecticut, 06606

Research Site, Hamden, Connecticut

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Recruiting

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Hamden, Connecticut, 06518

Research Site, Stamford, Connecticut

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Stamford, Connecticut, 06905

Research Site, Clearwater, Florida

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Research Site

Clearwater, Florida, 33756

Research Site, Inverness, Florida

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Inverness, Florida, 34452

Research Site, Lakewood Ranch, Florida

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Lakewood Ranch, Florida, 34211

Research Site, Atlanta, Georgia

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Atlanta, Georgia, 30328

Research Site, Columbus, Georgia

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Columbus, Georgia, 31904

Research Site, Macon, Georgia

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Macon, Georgia, 31201

Research Site, Stockbridge, Georgia

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Stockbridge, Georgia, 30281

Research Site, Stone Mountain, Georgia

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Stone Mountain, Georgia, 30083

Research Site, Sugar Hill, Georgia

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Sugar Hill, Georgia, 30518

Research Site, Idaho Falls, Idaho

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Idaho Falls, Idaho, 83404

Research Site, Arlington Heights, Illinois

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Arlington Heights, Illinois, 60005

Research Site, Melrose Park, Illinois

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Melrose Park, Illinois, 60160

Research Site, Morton, Illinois

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Morton, Illinois, 61550

Research Site, Clive, Iowa

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Clive, Iowa, 50325

Research Site, Iowa City, Iowa

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Iowa City, Iowa, 52242

Research Site, West Des Moines, Iowa

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West Des Moines, Iowa, 50266

Research Site, Topeka, Kansas

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Topeka, Kansas, 66606

Research Site, Lexington, Kentucky

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Lexington, Kentucky, 40509

Research Site, Lexington, Kentucky

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Lexington, Kentucky, 40536

Research Site, Louisville, Kentucky

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Louisville, Kentucky, 40202

Research Site, Crowley, Louisiana

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Research Site

Crowley, Louisiana, 70526

Research Site, Metairie, Louisiana

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Metairie, Louisiana, 70006

Research Site, New Orleans, Louisiana

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New Orleans, Louisiana, 70115

Research Site, New Orleans, Louisiana

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New Orleans, Louisiana, 70125

Research Site, Baltimore, Maryland

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Baltimore, Maryland, 21208

Research Site, Catonsville, Maryland

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Catonsville, Maryland, 21228

Research Site, Columbia, Maryland

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Columbia, Maryland, 21045

Research Site, Boston, Massachusetts

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Boston, Massachusetts, 02114

Research Site, Fall River, Massachusetts

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Fall River, Massachusetts, 02723

Research Site, Chesterfield, Michigan

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Chesterfield, Michigan, 48047

Research Site, Rochester, Michigan

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Rochester, Michigan, 48307

Research Site, Wyoming, Michigan

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Wyoming, Michigan, 49519

Research Site, Maplewood, Minnesota

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Maplewood, Minnesota, 55117

Research Site, Rochester, Minnesota

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Recruiting

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Rochester, Minnesota, 55905

Research Site, Petal, Mississippi

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Withdrawn

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Research Site

Petal, Mississippi, 39465

Research Site, Jefferson City, Missouri

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Withdrawn

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Research Site

Jefferson City, Missouri, 65109

Research Site, Saint Louis, Missouri

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Saint Louis, Missouri, 63141

Research Site, Omaha, Nebraska

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Withdrawn

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Omaha, Nebraska, 68114

Research Site, Omaha, Nebraska

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Recruiting

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Omaha, Nebraska, 68134

Research Site, Las Vegas, Nevada

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Withdrawn

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Las Vegas, Nevada, 89106

Research Site, Las Vegas, Nevada

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Las Vegas, Nevada, 89109

Research Site, Las Vegas, Nevada

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Las Vegas, Nevada, 89119

Research Site, Las Vegas, Nevada

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Las Vegas, Nevada, 89128

Research Site, Portsmouth, New Hampshire

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Portsmouth, New Hampshire, 03801

Research Site, Ocean Township, New Jersey

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Ocean Township, New Jersey, 07712

Research Site, Albuquerque, New Mexico

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Albuquerque, New Mexico, 87102

Research Site, Great Neck, New York

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Great Neck, New York, 11023

Research Site, Mineola, New York

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Mineola, New York, 11501

Research Site, New Windsor, New York

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New Windsor, New York, 12553

Research Site, New York, New York

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New York, New York, 10016

Research Site, Poughkeepsie, New York

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Poughkeepsie, New York, 12601

Research Site, Williamsville, New York

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Williamsville, New York, 14221

Research Site, Asheville, North Carolina

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Asheville, North Carolina, 28801

Research Site, Charlotte, North Carolina

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Charlotte, North Carolina, 28207

Research Site, Concord, North Carolina

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Concord, North Carolina, 28025

Research Site, Greenville, North Carolina

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Greenville, North Carolina, 27834

Research Site, Salisbury, North Carolina

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Salisbury, North Carolina, 28144

Research Site, Winston-Salem, North Carolina

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Winston-Salem, North Carolina, 27103

Research Site, Cincinnati, Ohio

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Cincinnati, Ohio, 45219

Research Site, Cleveland, Ohio

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Cleveland, Ohio, 44122

Research Site, Columbus, Ohio

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Columbus, Ohio, 43214

Research Site, Dayton, Ohio

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Dayton, Ohio, 45415

Research Site, Dayton, Ohio

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Dayton, Ohio, 45419

Research Site, Mentor, Ohio

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Mentor, Ohio, 44060

Research Site, Poland, Ohio

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Poland, Ohio, 44514

Research Site, Norman, Oklahoma

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Norman, Oklahoma, 73071

Research Site, Oklahoma City, Oklahoma

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Oklahoma City, Oklahoma, 73112

Research Site, Tulsa, Oklahoma

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Research Site

Tulsa, Oklahoma, 74104

Research Site, Philadelphia, Pennsylvania

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Recruiting

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Philadelphia, Pennsylvania, 19107

Research Site, Sayre, Pennsylvania

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Sayre, Pennsylvania, 18840

Research Site, Lincoln, Rhode Island

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Recruiting

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Lincoln, Rhode Island, 02865

Research Site, Warwick, Rhode Island

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Recruiting

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Warwick, Rhode Island, 02886

Research Site, Mount Pleasant, South Carolina

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Recruiting

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Mount Pleasant, South Carolina, 29464

Research Site, West Columbia, South Carolina

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West Columbia, South Carolina, 29169

Research Site, Sioux Falls, South Dakota

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Research Site

Sioux Falls, South Dakota, 57108

Research Site, Chattanooga, Tennessee

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Recruiting

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Research Site

Chattanooga, Tennessee, 37421

Research Site, Nashville, Tennessee

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Nashville, Tennessee, 37212

Research Site, Austin, Texas

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Recruiting

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Austin, Texas, 78704

Research Site, Austin, Texas

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Austin, Texas, 78726

Research Site, Austin, Texas

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Austin, Texas, 78745

Research Site, Cypress, Texas

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Research Site

Cypress, Texas, 77429

Research Site, Dallas, Texas

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Research Site

Dallas, Texas, 75224

Research Site, DeSoto, Texas

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DeSoto, Texas, 75115

Research Site, Garland, Texas

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Garland, Texas, 75044

Research Site, Harlingen, Texas

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Harlingen, Texas, 78550

Research Site, Houston, Texas

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Houston, Texas, 77025

Research Site, Houston, Texas

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Withdrawn

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Houston, Texas, 77058

Research Site, Houston, Texas

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Recruiting

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Houston, Texas, 77084

Research Site, McAllen, Texas

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Withdrawn

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Research Site

McAllen, Texas, 78503

Research Site, San Antonio, Texas

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Recruiting

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San Antonio, Texas, 78215

Research Site, Sugar Land, Texas

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Recruiting

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Research Site

Sugar Land, Texas, 77476

Research Site, Sugar Land, Texas

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Withdrawn

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Research Site

Sugar Land, Texas, 77479

Research Site, Victoria, Texas

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Recruiting

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Research Site

Victoria, Texas, 77904

Research Site, Ogden, Utah

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Recruiting

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Ogden, Utah, 84405

Research Site, Saint George, Utah

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Saint George, Utah, 84790

Research Site, Fairfax, Virginia

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Recruiting

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Fairfax, Virginia, 22031

Research Site, Gainesville, Virginia

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Withdrawn

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Gainesville, Virginia, 20155

Research Site, Lansdowne Town Center, Virginia

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Recruiting

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Lansdowne Town Center, Virginia, 20176

Research Site, Lynchburg, Virginia

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Recruiting

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Lynchburg, Virginia, 24502

Research Site, Norfolk, Virginia

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Recruiting

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Research Site

Norfolk, Virginia, 23507

Research Site, Bellevue, Washington

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Withdrawn

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Research Site

Bellevue, Washington, 98007

Research Site, Spokane, Washington

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Recruiting

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Research Site

Spokane, Washington, 99202

Research Site, Spokane, Washington

Status

Withdrawn

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Research Site

Spokane, Washington, 99204

Research Site, Vancouver, Washington

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Withdrawn

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Research Site

Vancouver, Washington, 98664

Research Site, Wauwatosa, Wisconsin

Status

Recruiting

Address

Research Site

Wauwatosa, Wisconsin, 53226

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