Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis

Last updated: March 19, 2024
Sponsor: Vanda Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetic Gastroparesis

Gastroparesis

Treatment

Tradipitant

Placebo

Open Label Tradipitant

Clinical Study ID

NCT04028492
VP-VLY-686-3301
  • Ages 18-70
  • All Genders

Study Summary

To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of gastroparesis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with gastroparesis
  • Demonstrated delayed gastric emptying
  • Presence of moderate to severe nausea
  • Body Mass Index (BMI) of ≥18 and ≤40 kg/m2

Exclusion

Exclusion Criteria:

  • Another active disorder or treatment which could explain or contribute to symptoms ofgastroparesis
  • A positive test for drugs of abuse at the screening or evaluation visits;
  • Exposure to any investigational medication in the past 60 days
  • Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastricstimulation device surgically implanted within the last year

Study Design

Total Participants: 201
Treatment Group(s): 3
Primary Treatment: Tradipitant
Phase: 3
Study Start date:
August 20, 2019
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Vanda Investigational Site

    Birmingham, Alabama 53244
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Peoria, Arizona 85381
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Little Rock, Arkansas 72211
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Chula Vista, California 91910
    United States

    Active - Recruiting

  • Vanda Investigational Site

    La Jolla, California 92093
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Los Angeles, California 90010
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Redwood City, California 94063
    United States

    Site Not Available

  • Vanda Investigational Site

    Denver, Colorado 80220
    United States

    Site Not Available

  • Vanda Investigational Site

    Wheat Ridge, Colorado 80033
    United States

    Site Not Available

  • Vanda Investigational Site

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Miami, Florida 33165
    United States

    Site Not Available

  • Vanda Investigational Site

    Palmetto Bay, Florida 33157
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Winter Springs, Florida 32708
    United States

    Site Not Available

  • Vanda Investigational Site

    Morrow, Georgia 30260
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Stone Mountain, Georgia 30083
    United States

    Site Not Available

  • Vanda Investigational Site

    Wauconda, Illinois 60084
    United States

    Active - Recruiting

  • Vanda Investigational Site

    West Des Moines, Iowa 50265
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Wichita, Kansas 67214
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Marrero, Louisiana 70072
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Baltimore, Maryland 21224
    United States

    Site Not Available

  • Vanda Investigational Site

    Chevy Chase, Maryland 20815
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Vanda Investigational Site

    Chesterfield, Missouri 63005
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Omaha, Nebraska 68134
    United States

    Site Not Available

  • Vanda Investigational Site

    Las Vegas, Nevada 89121
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Bronx, New York 10455
    United States

    Site Not Available

  • Vanda Investigational Site

    Brooklyn, New York 11201
    United States

    Active - Recruiting

  • Vanda Investigational Site

    New York, New York 10022
    United States

    Site Not Available

  • Vanda Investigational Site

    Charlotte, North Carolina 28209
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Raleigh, North Carolina 27612
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Columbus, Ohio 43214
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Huber Heights, Ohio 45424
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Edmond, Oklahoma 73034
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Tulsa, Oklahoma 74104
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • Vanda Investigational Site

    Chattanooga, Tennessee 37421
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Vanda Investigational Site

    Nashville, Tennessee 37211
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Arlington, Texas 76012
    United States

    Site Not Available

  • Vanda Investigational Site

    Houston, Texas 77043
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Plano, Texas 75024
    United States

    Active - Recruiting

  • Vanda Investigational Site

    San Antonio, Texas 78215
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Salt Lake City, Utah 84132
    United States

    Active - Recruiting

  • Vanda Investigational Site

    West Jordan, Utah 84088
    United States

    Site Not Available

  • Vanda Investigational Site

    Spokane, Washington 99202
    United States

    Site Not Available

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