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

September 14, 2026 updated by: Vanda Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

979

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tradipitant

Oral Capsule
Drug: Tradipitant

BID
Placebo Comparator: Placebo

Oral Capsule
Drug: Placebo

BID
Experimental: Open Label Tradipitant

Oral Capsule
Drug: Open Label Tradipitant

BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 12 in the Biweekly Average of Daily Nausea Severity Score Using MMRM Model ITT Population
Time Frame: 12 weeks

The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients to rate the worst occurrence of each cardinal symptom of gastroparesis (nausea severity, early satiety, postprandial fullness, bloating, and abdominal pain) in the past 24 hours on a Likert scale from 0 (no symptoms) to 5 (very severe). Change from baseline in average nausea severity score is calculated as the biweekly average post value minus baseline value of the daily nausea severity score from the GCSDD. A negative change indicates improvement.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Gastroparesis Cardinal Symptom Index (GCSI) Total Score Using MMRM Model ITT Population
Time Frame: 12 Weeks

The GCSI is a subject reported outcome administered in-clinic with a 2-week recall period to measure the severity of symptoms in gastroparesis. The GCSI is composed of 9 items based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). The severity of each symptom is rated on a six-point Likert response scale. The minimal scale value = 0 (none) and the maximum scale value = 5 (very severe). GCSI Total score is constructed as the average of the three symptom sub-scales. Higher score is indicative of greater symptom severity.
12 Weeks
Change From Baseline to Week 12 in the Biweekly Percentage of Nausea Free Days Using MMRM Model ITT Population
Time Frame: 12 Weeks

The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients if they have had any nausea over the past 24 hours and if yes, to rate the worst occurrence in the past 24 hours on a Likert scale from 1 (very mild) to 5 (very severe). Change in weekly percentage of nausea-free days from baseline is calculated as biweekly average post value minus baseline value.
12 Weeks
Change From Baseline in Overall Patient Benefit Scale (OPBS) ITT Population
Time Frame: 12 Weeks

The Overall Patient Benefit Scale (OPBS) is a weighted average of the recoded symptom improvement score of the five PRCGS items. The PRCGS data are recoded as follows: 3 - very much improved, 2 - much improved, 1 - minimally improved, 0 - no change or worse. The OPBS ranges from 0 to 3, with higher values indicating a better outcome.
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanda Pharmaceuticals

Investigators

  • Study Director: Vanda Pharmaceuticals, Vanda Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start (Actual)

August 20, 2019

Primary Completion (Actual)

February 21, 2025

Study Completion (Actual)

February 21, 2025

Study Registration Dates

First Submitted

July 10, 2019

First Submitted That Met QC Criteria

July 18, 2019

First Posted (Actual)

July 22, 2019

Study Record Updates

Last Update Posted (Actual)

September 24, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VLY-686-3301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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