Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis

Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18-70
SponsorVanda Pharmaceuticals

About this trial

Primary Objective: To treat a single patient with gastroparesis who has requested expanded access with tradipitant

Eligibility criteria

Qualifiers

Identified subject who requested expanded access

Diagnosed with gastroparesis

Demonstrated delayed gastric emptying

Presence of moderate to severe nausea

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Tradipitant

Treatment groups

No treatment groups listed

Locations

15
Florida
Vanda Investigational Site32751, Maitland United States
Vanda Investigational Site33613, Tampa United States
Illinois
Vanda Investigational Site60084, Wauconda United States
Kansas
Vanda Investigational Site67214, Wichita United States

Sponsors and collaborators

Vanda Pharmaceuticals

Lead sponsor