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Not recruiting
Phase 3

Tradipitant

Sponsor:

Vanda Pharmaceuticals

Code:

NCT04028492

Conditions

Idiopathic Gastroparesis

Diabetic Gastroparesis

Gastroparesis

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Tradipitant

Placebo

Open Label Tradipitant

Study Details

Brief summary:

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

Conditions

Idiopathic Gastroparesis

Diabetic Gastroparesis

Gastroparesis

Study ID

NCT04028492

Start date

Aug 20, 2019

Status verified date

Mar, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Enrollment

201 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tradipitant

Oral Capsule

placebo comparator: Placebo

Oral Capsule

experimental: Open Label Tradipitant

Oral Capsule

Interventions

Tradipitant

BID

Placebo

BID

Open Label Tradipitant

BID

Primary outcome measure

  • Change from baseline in daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary (GCS-DD) [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Vanda Pharmacuticals

202-734-3400clinicaltrials@vandapharma.com

Locations

Vanda Investigational Site

Recruiting

Birmingham, Alabama, United States, 53244

Vanda Investigational Site

Recruiting

Peoria, Arizona, United States, 85381

Vanda Investigational Site

Recruiting

Little Rock, Arkansas, United States, 72211

Contacts

202-734-3400

Vanda Investigational Site

Recruiting

Chula Vista, California, United States, 91910

Contacts

202-734-3400

Vanda Investigational Site

Recruiting

La Jolla, California, United States, 92093

Vanda Investigational Site

Recruiting

Los Angeles, California, United States, 90010

Vanda Investigational Site

Recruiting

Los Angeles, California, United States, 90026

Vanda Investigational Site

Recruiting

Maitland, Florida, United States, 32751

Vanda Investigational Site

Recruiting

Palmetto Bay, Florida, United States, 33157

Vanda Investigational Site

Recruiting

Tampa, Florida, United States, 33613

Contacts

202-734-3400

Vanda Investigational Site

Recruiting

Morrow, Georgia, United States, 30260

Vanda Investigational Site

Recruiting

Wauconda, Illinois, United States, 60084

Vanda Investigational Site

Recruiting

West Des Moines, Iowa, United States, 50265

Vanda Investigational Site

Recruiting

Wichita, Kansas, United States, 67214

Vanda Investigational Site

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

303-734-3400

Vanda Investigational Site

Recruiting

Marrero, Louisiana, United States, 70072

Contacts

202-734-3400

Vanda Investigational Site

Recruiting

Chevy Chase, Maryland, United States, 20815

Contacts

202-734-3400

Vanda Investigational Site

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

202-734-3400

Vanda Investigational Site

Recruiting

Boston, Massachusetts, United States, 02115

Vanda Investigational Site

Recruiting

Chesterfield, Missouri, United States, 63005

Vanda Investigational Site

Recruiting

Las Vegas, Nevada, United States, 89121

Contacts

202-734-3400

Vanda Investigational Site

Recruiting

Brooklyn, New York, United States, 11201

Contacts

202-734-3400

Vanda Investigational Site

Recruiting

Charlotte, North Carolina, United States, 28209

Vanda Investigational Site

Recruiting

Raleigh, North Carolina, United States, 27612

Contacts

202-734-3400

Vanda Investigational Site

Recruiting

Columbus, Ohio, United States, 43214

Vanda Investigational Site

Recruiting

Huber Heights, Ohio, United States, 45424

Contacts

202-734-3400

Vanda Investigational Site

Recruiting

Edmond, Oklahoma, United States, 73034

Vanda Investigational Site

Recruiting

Tulsa, Oklahoma, United States, 74104

Contacts

202-734-3400

Vanda Investigational Site

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Vanda Investigational Site

Recruiting

Chattanooga, Tennessee, United States, 37421

Contacts

202-734-3400

Vanda Investigational Site

Recruiting

Nashville, Tennessee, United States, 37211

Contacts

202-734-3400

Vanda Investigational Site

Recruiting

Houston, Texas, United States, 77043

Vanda Investigational Site

Recruiting

Houston, Texas, United States, 77084

Vanda Investigational Site

Recruiting

Plano, Texas, United States, 75024

Vanda Investigational Site

Recruiting

San Antonio, Texas, United States, 78215

Vanda Investigational Site

Recruiting

Salt Lake City, Utah, United States, 84132

More Information

Sponsor

Vanda Pharmaceuticals

Last update posted

Mar 22, 2024

Last verified

Mar, 2024

Keywords

  • gastroparesis
  • idiopathic
  • diabetic
  • tradipitant
  • nausea
  • vomiting
  • stomach
  • motility
  • functional
  • NK-1 antagonist
  • neurokinin 1 receptor
  • substance p

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-29. This information was provided to ClinicalTrials.gov by Vanda Pharmaceuticals on 2024-03-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.