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

March 19, 2024 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

201

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 Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 53244
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • 202-734-3400
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • 202-734-3400
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Phone Number: 202-734-3400
    • California
      • Chula Vista, California, United States, 91910
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Phone Number: 202-734-3400
      • La Jolla, California, United States, 92093
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • 202-734-3400
      • Los Angeles, California, United States, 90026
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • 202-734-3400
      • Los Angeles, California, United States, 90010
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • 202-734-3400
    • Florida
      • Maitland, Florida, United States, 32751
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • 202-734-3400
      • Palmetto Bay, Florida, United States, 33157
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • 202-734-3400
      • Tampa, Florida, United States, 33613
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Phone Number: 202-734-3400
    • Georgia
      • Morrow, Georgia, United States, 30260
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • 202-734-3400
    • Illinois
      • Wauconda, Illinois, United States, 60084
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • 202-734-3400
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • 202-734-3400
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • 202-734-3400
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Phone Number: 303-734-3400
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Phone Number: 202-734-3400
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Phone Number: 202-734-3400
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • 202-734-3400
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Phone Number: 202-734-3400
    • Missouri
      • Chesterfield, Missouri, United States, 63005
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • 202-734-3400
    • Nevada
      • Las Vegas, Nevada, United States, 89121
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Phone Number: 202-734-3400
    • New York
      • Brooklyn, New York, United States, 11201
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Phone Number: 202-734-3400
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • 202-734-3400
      • Raleigh, North Carolina, United States, 27612
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Phone Number: 202-734-3400
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • 202-734-3400
      • Huber Heights, Ohio, United States, 45424
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Phone Number: 202-734-3400
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • 202-734-3400
      • Tulsa, Oklahoma, United States, 74104
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Phone Number: 202-734-3400
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • 202-734-3400
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Phone Number: 202-734-3400
      • Nashville, Tennessee, United States, 37211
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Phone Number: 202-734-3400
    • Texas
      • Houston, Texas, United States, 77043
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • 202-734-3400
      • Houston, Texas, United States, 77084
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • 202-734-3400
      • Plano, Texas, United States, 75024
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • 202-734-3400
      • San Antonio, Texas, United States, 78215
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • 202-734-3400
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • 202-734-3400

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

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 in daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary (GCS-DD)
Time Frame: 12 weeks
A daily symptom diary asking patients to rate their nausea on a Likert scale from 0-5 (0=none, 5= very severe).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in other average core gastroparesis symptoms from the Gastroparesis Core Symptom Daily Diary
Time Frame: 12 weeks
A patient reported daily symptom diary asking patients to rate their nausea on a Likert scale from 0-5 (0=none, 5= very severe). Other symptoms include vomiting, postprandial fullness, early satiety, and abdominal pain
12 weeks
Change from baseline in Patient Assessment of Gastrointestinal Disorders - Symptoms Severity Index (PAGI-SYM)
Time Frame: 12 weeks
PAGI-SYM is a patient reported outcome that measures specific symptoms of patients with upper gastrointestinal disorders such as gastroparesis, GERD, and dyspepsia on a 0-5 Likert Scale (0=none, 5=very severe).
12 weeks
Change from baseline in Patient Global Impression - Change (PGI-C)
Time Frame: 12 weeks
A patient reported outcome measuring a patient's rating of overall improvement after treatment on a 7 point scale that includes items "1=very much worse" and "7=very much improved"
12 weeks
Clinician Global Impression - Severity (CGI-S)
Time Frame: 12 weeks
A clinician reported outcome that measures the clinician's view of the patient's global functioning prior to and after initiating treatment. Symptom severity is measured on a 7 point scale including "1=normal, not at all ill" and "7=among the most extremely ill patients."
12 weeks
Safety and tolerability as measured by spontaneous reporting of adverse events (AEs)
Time Frame: 12 weeks
Safety will be monitored using clinical measures, vital signs, blood chemistry, hematology, urology, ECGs, and patient reported questionnaires.
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 (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

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)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

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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