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

Description

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

Conditions

Idiopathic Gastroparesis, Diabetic Gastroparesis, Gastroparesis

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Idiopathic Gastroparesis
Intervention / Treatment

-

Contacts and Locations

Birmingham

Vanda Investigational Site, Birmingham, Alabama, United States, 53244

Peoria

Vanda Investigational Site, Peoria, Arizona, United States, 85381

Little Rock

Vanda Investigational Site, Little Rock, Arkansas, United States, 72211

Chula Vista

Vanda Investigational Site, Chula Vista, California, United States, 91910

La Jolla

Vanda Investigational Site, La Jolla, California, United States, 92093

Los Angeles

Vanda Investigational Site, Los Angeles, California, United States, 90010

Los Angeles

Vanda Investigational Site, Los Angeles, California, United States, 90026

Maitland

Vanda Investigational Site, Maitland, Florida, United States, 32751

Palmetto Bay

Vanda Investigational Site, Palmetto Bay, Florida, United States, 33157

Tampa

Vanda Investigational Site, Tampa, Florida, United States, 33613

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vanda Pharmaceuticals,

Vanda Pharmaceuticals, STUDY_DIRECTOR, Vanda Pharmaceuticals

Study Record Dates

2024-12