Clinical trial NCT04474990: Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis
Official title: VP-VLY-686-3303: Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Gastroparesis
Diabetic Gastroparesis
Keywords: gastroparesis
idiopathic
diabetic
tradipitant
nausea
vomiting
stomach
motility
functional
NK-1 antagonist
neurokinin 1 receptor
substance p
expanded access
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-07-17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT

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 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

Eligibility criteria: 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;

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Vanda Investigational Site
state: Florida
city: Tampa
country: United States
facility: Vanda Investigational Site
state: Florida
city: Wauconda
country: United States
facility: Vanda Investigational Site
state: Illinois
city: Wichita
country: United States
facility: Vanda Investigational Site
state: Kansas
city: Louisville
country: United States
facility: Vanda Investigational Site
state: Kentucky
city: Chevy Chase
country: United States
facility: Vanda Investigational Site
state: Maryland
city: Boston
country: United States
facility: Vanda Investigational Site
state: Massachusetts
city: Chesterfield
country: United States
facility: Vanda Investigational Site
state: Missouri
city: Charlotte
country: United States
facility: Vanda Investigational Site
state: North Carolina
city: Tulsa
country: United States
facility: Vanda Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Vanda Investigational Site
state: Pennsylvania
city: Nashville
country: United States
facility: Vanda Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Vanda Investigational Site
state: Texas
city: Plano
country: United States
facility: Vanda Investigational Site
state: Texas
city: Spokane
country: United States
facility: Vanda Investigational Site
state: Washington
Study officials:
References: