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

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

Official Title
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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

Conditions
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Idiopathic Gastroparesis, Diabetic Gastroparesis, Gastroparesis

Intervention / Treatment
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* Drug: Tradipitant
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tradipitant<br>Oral Capsule | Drug: Tradipitant<br>* BID<br>|
| Placebo Comparator: Placebo<br>Oral Capsule | Drug: Placebo<br>* BID<br>|

What is the study measuring?
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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) | 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 | 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) | 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) | 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) | 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) | Safety will be monitored using clinical measures, vital signs, blood chemistry, hematology, urology, ECGs, and patient reported questionnaires. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastroparesis, idiopathic, diabetic, tradipitant, nausea, vomiting, stomach, motility, functional, NK-1 antagonist, neurokinin 1 receptor, substance p