Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis

A Multicenter, Open Label, 3-Month Safety Study with Tradipitant in Patients with Idiopathic or Diabetic Gastroparesis

This is a multicenter, open label, 3-month safety study with tradipitant in patients with idiopathic and diabetic gastroparesis.

Study Overview

• Status: Recruiting
• Conditions: Gastroparesis; Diabetic Gastroparesis; Idiopathic Gastroparesis
• Intervention / Treatment: Drug: Tradipitant

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Vanda Pharmaceuticals; Phone Number: 202-734-3400; Email: clinicaltrials@vandapharma.com

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • Vanda Investigational Site
    • Contact: Phone Number: 202-734-3400
  • Liège, Belgium, 4000
    • Recruiting
    • Vanda Investigational Site
    • Contact: Phone Number: 202-734-3400
• Germany
  • Leipzig, Germany, 04103
    • Recruiting
    • Vanda Investigational Site
    • Contact: Phone Number: 202-734-3400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 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
• Pregnancy or nursing
• Evidence of uncontrolled blood glucose (including HbA1C >11% at screening or metabolic crisis in past 60 days)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open Label Tradipitant; Oral Capsule	Drug: Tradipitant; BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events (AEs), including suicidal ideation or behavior as measured by the C-SSRS	AEs will be coded using the MedDRA coding dictionary. An AE is defined as any untoward medical occurrence in a clinical investigation subject that does not necessarily have causal relationship with treatment. AEs will further be categorized by severity, relationship to study medication, and action taken. All AEs will be presented in data listings for subjects. The Columbia-Suicide Severity Rating Scale (C-SSRS) is a semi-structured clinical interview designed to systematically assess and track suicidal adverse events (behavior and ideation) throughout different settings including clinical trials. Results from the C-SSRS will be listed for each subject. These data will also be summarized for all subjects for suicidal ideation events, suicidal behaviors, and completed suicides.	12 weeks
Number of participants with changes in vital signs identified as Clinically Notable Abnormal values	Vital sign measurements include oral temperature (C), respiratory rate, semi-supine blood pressure (systolic and diastolic) (mmHg) and semi-supine heart rate (bpm). Criteria for identifying vital signs as Potentially Clinically Notable Abnormalities are based on the Guidelines for the Division of Neuropharmacological Drug Products. Data from vital signs will be listed, clinically notable values will be flagged, and other information collected will be listed. Data will also be summarized using mean change from first study visit and proportion of subjects with values outside the normal range, and values that were clinically notable.	12 weeks
Number of participants with abnormal and potentially Clinically Notable Abnormal Electrocardiogram Intervals and Heart Rate	Variables include PR (ms), QRS (ms), QTc (ms), and Heart Rate (bpm). Note: ms = millisecond; bpm = beats per minute	12 weeks
Number of participants with Clinically Notable Abnormal laboratory values	Laboratory data will be summarized by presenting the proportions of patients with clinically notable abnormalities as follows: shift tables, first study visit to most extreme post-treatment value, using normal ranges; summary statistics of raw data and change from first study visit values (means, medians, standard deviations, ranges). Criteria for identifying laboratory values as Potentially Clinically Notable Abnormalities are based on the FDA's Guidelines for the Division of Neuropharmacological Drug Products.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the efficacy of tradipitant in reducing individual symptoms associated with gastroparesis	Efficacy is assessed by the Gastroparesis Core Symptom Daily Diary (GCSDD). The GCSDD is a 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
To evaluate the efficacy of tradipitant in global improvement	Efficacy is assessed by the Clinical Global Impression - Severity (CGI-S). The CGI-S is 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

Collaborators and Investigators

• Sponsor: Vanda Pharmaceuticals
• Investigators: Study Director: Vanda Pharmaceuticals, Vanda Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 1, 2024
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: nausea; functional; vomiting; stomach; motility; gastroparesis; idiopathic; diabetic; tradipitant; NK-1 antagonist; neurokinin 1 receptor; substance p
• Additional Relevant MeSH Terms: Neurologic Manifestations; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: VP-VLY-686-3304

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
• product manufactured in and exported from the U.S.: No