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Completed

NCT Number: NCT04028492

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

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

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Key information

Conditions

Idiopathic Gastroparesis Diabetic Gastroparesis Digestive System Diseases Gastrointestinal Diseases Gastroparesis Nausea Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Stomach Diseases Vomiting

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vanda Investigational Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tradipitant

Drug

BID

Placebo

Drug

BID

Open Label Tradipitant

Drug

BID

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. 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).

  3. 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"

  4. 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."

  5. 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.

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2019
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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