Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis
NCT ID: NCT04474990
Last Updated: 2025-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Patient will be given open label tradipitant 85 mg to be taken twice daily at 12 hour intervals for long term treatment. Patient can fill out daily web-based symptom diaries on a voluntary basis and report any adverse events to Investigator-Physician.
Primary Objective:
-To treat a single patient with gastroparesis who has requested expanded access with tradipitant
Secondary Objectives:
* To monitor the efficacy of tradipitant in reducing individual symptoms associated with gastroparesis in this single patient
* To monitor the safety of tradipitant in a patient with gastroparesis by assessing adverse events in this single patient
Conditions
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Interventions
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Tradipitant
NK-1 Receptor antagonist
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with gastroparesis
* Demonstrated delayed gastric emptying
* Presence of moderate to severe nausea
* Patient does not qualify for or does not have access to other clinical trials with tradipitant;
Exclusion Criteria
* A positive test for drugs of abuse at the screening or evaluation visits;
* Exposure to any investigational medication in the past 60 days other than tradipitant
* Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year
* Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit ratio to treatment;
18 Years
70 Years
ALL
No
Sponsors
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Vanda Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Vanda Investigational Site
Maitland, Florida, United States
Vanda Investigational Site
Tampa, Florida, United States
Vanda Investigational Site
Wauconda, Illinois, United States
Vanda Investigational Site
Wichita, Kansas, United States
Vanda Investigational Site
Louisville, Kentucky, United States
Vanda Investigational Site
Chevy Chase, Maryland, United States
Vanda Investigational Site
Boston, Massachusetts, United States
Vanda Investigational Site
Chesterfield, Missouri, United States
Vanda Investigational Site
Charlotte, North Carolina, United States
Vanda Investigational Site
Tulsa, Oklahoma, United States
Vanda Investigational Site
Philadelphia, Pennsylvania, United States
Vanda Investigational Site
Nashville, Tennessee, United States
Vanda Investigational Site
Houston, Texas, United States
Vanda Investigational Site
Plano, Texas, United States
Vanda Investigational Site
Spokane, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
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Role: primary
Role: primary
Role: primary
Role: primary
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Role: primary
Role: primary
Other Identifiers
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VP-VLY-686-3303
Identifier Type: -
Identifier Source: org_study_id
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