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

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified January 2025 by Vanda Pharmaceuticals
Sponsor
Vanda Pharmaceuticals
Information Provided by (Responsible Party)
Vanda Pharmaceuticals
Clinicaltrials.gov Identifier
NCT04028492
Other Study ID Numbers:
VP-VLY-686-3301
First Submitted
July 9, 2019
First Posted
July 21, 2019
Last Update Posted
July 23, 2025
Last Verified
January 2025

ClinicalTrials.gov processed this data on July 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Idiopathic GastroparesisDiabetic GastroparesisGastroparesis
Drug: TradipitantDrug: PlaceboDrug: Open Label Tradipitant

Study Design

Study TypeInterventional
Actual Enrollment992 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleVP-VLY-686-3301: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Iii Study To Assess The Efficacy Of Tradipitant In Relieving Symptoms Of Gastroparesis
Study Start DateAugust 19, 2019
Actual Primary Completion DateFebruary 20, 2025
Actual Study Completion DateFebruary 20, 2025

Groups and Cohorts

Group/CohortIntervention/Treatment
Tradipitant
Oral Capsule
Drug: Tradipitant
BID
Placebo
Oral Capsule
Drug: Placebo
BID
Open Label Tradipitant
Oral Capsule
Drug: Open Label Tradipitant
BID

Outcome Measures

Primary Outcome Measures
  1. Change from baseline in daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary (GCS-DD)
    A daily symptom diary asking patients to rate their nausea on a Likert scale from 0-5 (0=none, 5= very severe).
Secondary Outcome Measures
  1. Change from baseline in other average core gastroparesis symptoms from the Gastroparesis Core Symptom Daily Diary
    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
  2. Change from baseline in Patient Assessment of Gastrointestinal Disorders - Symptoms Severity Index (PAGI-SYM)
    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).
  3. Change from baseline in Patient Global Impression - Change (PGI-C)
    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"
  4. Clinician Global Impression - Severity (CGI-S)
    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."
  5. Safety and tolerability as measured by spontaneous reporting of adverse events (AEs)
    Safety will be monitored using clinical measures, vital signs, blood chemistry, hematology, urology, ECGs, and patient reported questionnaires.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsVanda Pharmaceuticals
Locations
Vanda Investigational Site | Birmingham Alabama, United States, 53244Vanda Investigational Site | Peoria Arizona, United States, 85381Vanda Investigational Site | Little Rock Arkansas, United States, 72211Vanda Investigational Site | Chula Vista California, United States, 91910Vanda Investigational Site | La Jolla California, United States, 92093Vanda Investigational Site | Los Angeles California, United States, 90010Vanda Investigational Site | Los Angeles California, United States, 90026Vanda Investigational Site | Maitland Florida, United States, 32751Vanda Investigational Site | Palmetto Bay Florida, United States, 33157Vanda Investigational Site | Tampa Florida, United States, 33613Vanda Investigational Site | Morrow Georgia, United States, 30260Vanda Investigational Site | Wauconda Illinois, United States, 60084Vanda Investigational Site | West Des Moines Iowa, United States, 50265Vanda Investigational Site | Wichita Kansas, United States, 67214Vanda Investigational Site | Louisville Kentucky, United States, 40202Vanda Investigational Site | Marrero Louisiana, United States, 70072Vanda Investigational Site | Chevy Chase Maryland, United States, 20815Vanda Investigational Site | Boston Massachusetts, United States, 02114Vanda Investigational Site | Boston Massachusetts, United States, 02115Vanda Investigational Site | Chesterfield Missouri, United States, 63005Vanda Investigational Site | Las Vegas Nevada, United States, 89121Vanda Investigational Site | Brooklyn New York, United States, 11201Vanda Investigational Site | Charlotte North Carolina, United States, 28209Vanda Investigational Site | Raleigh North Carolina, United States, 27612Vanda Investigational Site | Columbus Ohio, United States, 43214Vanda Investigational Site | Huber Heights Ohio, United States, 45424Vanda Investigational Site | Edmond Oklahoma, United States, 73034Vanda Investigational Site | Tulsa Oklahoma, United States, 74104Vanda Investigational Site | Philadelphia Pennsylvania, United States, 19104Vanda Investigational Site | Chattanooga Tennessee, United States, 37421Vanda Investigational Site | Nashville Tennessee, United States, 37211Vanda Investigational Site | Houston Texas, United States, 77043Vanda Investigational Site | Houston Texas, United States, 77084Vanda Investigational Site | Plano Texas, United States, 75024Vanda Investigational Site | San Antonio Texas, United States, 78215Vanda Investigational Site | Salt Lake City Utah, United States, 84132
Investigators
Study Director: Vanda Pharmaceuticals, Vanda Pharmaceuticals
Study Documents (Full Text)
Documents provided by Vanda Pharmaceuticals: Study Protocol  October 26, 2022Documents provided by Vanda Pharmaceuticals: Statistical Analysis Plan  October 26, 2022