Status:
AVAILABLE
Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis
Lead Sponsor:
Vanda Pharmaceuticals
Conditions:
Gastroparesis
Diabetic Gastroparesis
Eligibility:
All Genders
18-70 years
Brief Summary
Primary Objective: To treat a single patient with gastroparesis who has requested expanded access with tradipitant
Detailed Description
This is a single-patient extended access treatment protocol to be conducted in the United States. Investigator-Physician has determined patient satisfies expanded access inclusion criteria and has req...
Eligibility Criteria
Inclusion
- Identified subject who requested expanded access
- 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
- 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 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;
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04474990
Last Update
August 24 2025
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Vanda Investigational Site
Maitland, Florida, United States, 32751
2
Vanda Investigational Site
Tampa, Florida, United States, 33613
3
Vanda Investigational Site
Wauconda, Illinois, United States, 60084
4
Vanda Investigational Site
Wichita, Kansas, United States, 67214