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

a study on Idiopathic Gastroparesis Diabetes Gastroparesis

Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at UCSD
Dates
study started
completion around
Principal Investigator
by David Kunkel (ucsd)
Headshot of David Kunkel
David Kunkel

Description

Summary

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

Keywords

Idiopathic Gastroparesis, Diabetic Gastroparesis, Gastroparesis, idiopathic, diabetic, tradipitant, nausea, vomiting, stomach, motility, functional, NK-1 antagonist, neurokinin 1 receptor, substance p, Open Label Tradipitant

Eligibility

You can join if…

Open to people ages 18-70

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

You CAN'T join if...

  • 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

Locations

  • Vanda Investigational Site accepting new patients
    La Jolla California 92093 United States
  • Vanda Investigational Site accepting new patients
    Los Angeles California 90010 United States
  • Vanda Investigational Site accepting new patients
    Los Angeles California 90026 United States
  • Vanda Investigational Site accepting new patients
    Chula Vista California 91910 United States

Lead Scientist at University of California Health

  • David Kunkel (ucsd)
    Associate Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 39 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vanda Pharmaceuticals
Links
Study Website
ID
NCT04028492
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 201 study participants
Last Updated