Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis (NCT04474990) | Clinical Trial Compass
AVAILABLENot Applicable
Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis
United States
Plain-language summary
Primary Objective: To treat a single patient with gastroparesis who has requested expanded access with tradipitant
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 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 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;