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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04028492
Recruitment Status : Recruiting
First Posted : July 22, 2019
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Idiopathic Gastroparesis Diabetic Gastroparesis Gastroparesis Drug: Tradipitant Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : August 20, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Tradipitant
Oral Capsule
 Drug: Tradipitant
BID
Placebo Comparator: Placebo
Oral Capsule
 Drug: Placebo
BID


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04028492


Contacts
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Contact: Vanda Pharmacuticals 202-734-3400 clinicaltrials@vandapharma.com

Locations
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Sponsors and Collaborators
Vanda Pharmaceuticals
Investigators
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Study Director: Vanda Pharmaceuticals Vanda Pharmaceuticals
More Information
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Additional Information:

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Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04028492    
Other Study ID Numbers: VP-VLY-686-3301
First Posted: July 22, 2019    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vanda Pharmaceuticals:
gastroparesis
idiopathic
diabetic
tradipitant
nausea
vomiting
 stomach
motility
functional
NK-1 antagonist
neurokinin 1 receptor
substance p
Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Paralysis
Neurologic Manifestations