Primary Objective: To treat a single patient with gastroparesis who has requestedexpanded access with tradipitant
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 requested expanded access to tradipitant.
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
Drug: Tradipitant
NK-1 Receptor antagonist
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;
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
Vanda Pharmaceuticals
2027343400
clinicaltrials@vandapharma.com