COMPLETED

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

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Conditions

Idiopathic GastroparesisDiabetic GastroparesisGastroparesisidiopathicdiabetictradipitantnauseavomitingstomachmotilityfunctionalNK-1 antagonistneurokinin 1 receptorsubstance p

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

VP-VLY-686-3301: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Iii Study To Assess The Efficacy Of Tradipitant In Relieving Symptoms Of Gastroparesis

Quick Facts

Study Start:2019-08-20
Study Completion:2025-02-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04028492

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed with gastroparesis
  2. * Demonstrated delayed gastric emptying
  3. * Presence of moderate to severe nausea
  4. * Body Mass Index (BMI) of ≥18 and ≤40 kg/m2
  1. * Another active disorder or treatment which could explain or contribute to symptoms of gastroparesis
  2. * A positive test for drugs of abuse at the screening or evaluation visits;
  3. * Exposure to any investigational medication in the past 60 days
  4. * Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year

Contacts and Locations

Principal Investigator

Vanda Pharmaceuticals
STUDY_DIRECTOR
Vanda Pharmaceuticals

Study Locations (Sites)

Vanda Investigational Site
Birmingham, Alabama, 53244
United States
Vanda Investigational Site
Peoria, Arizona, 85381
United States
Vanda Investigational Site
Little Rock, Arkansas, 72211
United States
Vanda Investigational Site
Chula Vista, California, 91910
United States
Vanda Investigational Site
La Jolla, California, 92093
United States
Vanda Investigational Site
Los Angeles, California, 90010
United States
Vanda Investigational Site
Los Angeles, California, 90026
United States
Vanda Investigational Site
Maitland, Florida, 32751
United States
Vanda Investigational Site
Palmetto Bay, Florida, 33157
United States
Vanda Investigational Site
Tampa, Florida, 33613
United States
Vanda Investigational Site
Morrow, Georgia, 30260
United States
Vanda Investigational Site
Wauconda, Illinois, 60084
United States
Vanda Investigational Site
West Des Moines, Iowa, 50265
United States
Vanda Investigational Site
Wichita, Kansas, 67214
United States
Vanda Investigational Site
Louisville, Kentucky, 40202
United States
Vanda Investigational Site
Marrero, Louisiana, 70072
United States
Vanda Investigational Site
Chevy Chase, Maryland, 20815
United States
Vanda Investigational Site
Boston, Massachusetts, 02114
United States
Vanda Investigational Site
Boston, Massachusetts, 02115
United States
Vanda Investigational Site
Chesterfield, Missouri, 63005
United States
Vanda Investigational Site
Las Vegas, Nevada, 89121
United States
Vanda Investigational Site
Brooklyn, New York, 11201
United States
Vanda Investigational Site
Charlotte, North Carolina, 28209
United States
Vanda Investigational Site
Raleigh, North Carolina, 27612
United States
Vanda Investigational Site
Columbus, Ohio, 43214
United States
Vanda Investigational Site
Huber Heights, Ohio, 45424
United States
Vanda Investigational Site
Edmond, Oklahoma, 73034
United States
Vanda Investigational Site
Tulsa, Oklahoma, 74104
United States
Vanda Investigational Site
Philadelphia, Pennsylvania, 19104
United States
Vanda Investigational Site
Chattanooga, Tennessee, 37421
United States
Vanda Investigational Site
Nashville, Tennessee, 37211
United States
Vanda Investigational Site
Houston, Texas, 77043
United States
Vanda Investigational Site
Houston, Texas, 77084
United States
Vanda Investigational Site
Plano, Texas, 75024
United States
Vanda Investigational Site
San Antonio, Texas, 78215
United States
Vanda Investigational Site
Salt Lake City, Utah, 84132
United States

Collaborators and Investigators

Sponsor: Vanda Pharmaceuticals

  • Vanda Pharmaceuticals, STUDY_DIRECTOR, Vanda Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-20
Study Completion Date2025-02-21

Study Record Updates

Study Start Date2019-08-20
Study Completion Date2025-02-21

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Idiopathic Gastroparesis
  • Diabetic Gastroparesis
  • Gastroparesis