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

Purpose

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

Conditions

  • Idiopathic Gastroparesis
  • Diabetic Gastroparesis
  • Gastroparesis

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Criteria

  • Another active disorder or treatment which could explain or contribute to symptoms of gastroparesis - 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 gastric stimulation device surgically implanted within the last year

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tradipitant 		Oral Capsule
  • Drug: Tradipitant
    BID
  • Drug: Open Label Tradipitant
    BID
Placebo Comparator
Placebo 		Oral Capsule
  • Drug: Placebo
    BID
Experimental
Open Label Tradipitant 		Oral Capsule
  • Drug: Open Label Tradipitant
    BID

Recruiting Locations

Vanda Investigational Site
Birmingham, Alabama 53244
Contact:
202-734-3400

Vanda Investigational Site
Peoria, Arizona 85381
Contact:
202-734-3400

Vanda Investigational Site
Little Rock, Arkansas 72211
Contact:
202-734-3400

Vanda Investigational Site
Chula Vista, California 91910
Contact:
202-734-3400

Vanda Investigational Site
La Jolla, California 92093
Contact:
202-734-3400

Vanda Investigational Site
Los Angeles, California 90010
Contact:
202-734-3400

Vanda Investigational Site
Los Angeles, California 90026
Contact:
202-734-3400

Vanda Investigational Site
Maitland, Florida 32751
Contact:
202-734-3400

Vanda Investigational Site
Palmetto Bay, Florida 33157
Contact:
202-734-3400

Vanda Investigational Site
Tampa, Florida 33613
Contact:
202-734-3400

Vanda Investigational Site
Morrow, Georgia 30260
Contact:
202-734-3400

Vanda Investigational Site
Wauconda, Illinois 60084
Contact:
202-734-3400

Vanda Investigational Site
West Des Moines, Iowa 50265
Contact:
202-734-3400

Vanda Investigational Site
Wichita, Kansas 67214
Contact:
202-734-3400

Vanda Investigational Site
Louisville, Kentucky 40202
Contact:
303-734-3400

Vanda Investigational Site
Marrero, Louisiana 70072
Contact:
202-734-3400

Vanda Investigational Site
Chevy Chase, Maryland 20815
Contact:
202-734-3400

Vanda Investigational Site
Boston, Massachusetts 02114
Contact:
202-734-3400

Vanda Investigational Site
Boston, Massachusetts 02115
Contact:
202-734-3400

Vanda Investigational Site
Chesterfield, Missouri 63005
Contact:
202-734-3400

Vanda Investigational Site
Las Vegas, Nevada 89121
Contact:
202-734-3400

Vanda Investigational Site
Brooklyn, New York 11201
Contact:
202-734-3400

Vanda Investigational Site
Charlotte, North Carolina 28209
Contact:
202-734-3400

Vanda Investigational Site
Raleigh, North Carolina 27612
Contact:
202-734-3400

Vanda Investigational Site
Columbus, Ohio 43214
Contact:
202-734-3400

Vanda Investigational Site
Huber Heights, Ohio 45424
Contact:
202-734-3400

Vanda Investigational Site
Edmond, Oklahoma 73034
Contact:
202-734-3400

Vanda Investigational Site
Tulsa, Oklahoma 74104
Contact:
202-734-3400

Vanda Investigational Site
Philadelphia, Pennsylvania 19104
Contact:
202-734-3400

Vanda Investigational Site
Chattanooga, Tennessee 37421
Contact:
202-734-3400

Vanda Investigational Site
Nashville, Tennessee 37211
Contact:
202-734-3400

Vanda Investigational Site
Houston, Texas 77043
Contact:
202-734-3400

Vanda Investigational Site
Houston, Texas 77084
Contact:
202-734-3400

Vanda Investigational Site
Plano, Texas 75024
Contact:
202-734-3400

Vanda Investigational Site
San Antonio, Texas 78215
Contact:
202-734-3400

Vanda Investigational Site
Salt Lake City, Utah 84132
Contact:
202-734-3400

More Details

NCT ID
NCT04028492
Status
Recruiting
Sponsor
Vanda Pharmaceuticals

Study Contact

Vanda Pharmacuticals
202-734-3400
clinicaltrials@vandapharma.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center