Clinical trial NCT04028492: Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis
Official title: VP-VLY-686-3301: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Iii Study To Assess The Efficacy Of Tradipitant In Relieving Symptoms Of Gastroparesis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Idiopathic Gastroparesis
Diabetic Gastroparesis
Gastroparesis
Keywords: gastroparesis
idiopathic
diabetic
tradipitant
nausea
vomiting
stomach
motility
functional
NK-1 antagonist
neurokinin 1 receptor
substance p
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-07-22
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of gastroparesis.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with gastroparesis
* Demonstrated delayed gastric emptying
* Presence of moderate to severe nausea
* Body Mass Index (BMI) of ≥18 and ≤40 kg/m2

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
* Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year

Primary outcomes:
measure: Change from baseline in daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary (GCS-DD)
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline in other average core gastroparesis symptoms from the Gastroparesis Core Symptom Daily Diary
timeFrame: 12 weeks
measure: Change from baseline in Patient Assessment of Gastrointestinal Disorders - Symptoms Severity Index (PAGI-SYM)
timeFrame: 12 weeks
measure: Change from baseline in Patient Global Impression - Change (PGI-C)
timeFrame: 12 weeks
measure: Clinician Global Impression - Severity (CGI-S)
timeFrame: 12 weeks
measure: Safety and tolerability as measured by spontaneous reporting of adverse events (AEs)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Vanda Investigational Site
state: Alabama
city: Peoria
country: United States
facility: Vanda Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Vanda Investigational Site
state: Arkansas
city: Chula Vista
country: United States
facility: Vanda Investigational Site
state: California
city: La Jolla
country: United States
facility: Vanda Investigational Site
state: California
city: Los Angeles
country: United States
facility: Vanda Investigational Site
state: California
city: Los Angeles
country: United States
facility: Vanda Investigational Site
state: California
city: Maitland
country: United States
facility: Vanda Investigational Site
state: Florida
city: Palmetto Bay
country: United States
facility: Vanda Investigational Site
state: Florida
city: Tampa
country: United States
facility: Vanda Investigational Site
state: Florida
city: Morrow
country: United States
facility: Vanda Investigational Site
state: Georgia
city: Wauconda
country: United States
facility: Vanda Investigational Site
state: Illinois
city: West Des Moines
country: United States
facility: Vanda Investigational Site
state: Iowa
city: Wichita
country: United States
facility: Vanda Investigational Site
state: Kansas
city: Louisville
country: United States
facility: Vanda Investigational Site
state: Kentucky
city: Marrero
country: United States
facility: Vanda Investigational Site
state: Louisiana
city: Chevy Chase
country: United States
facility: Vanda Investigational Site
state: Maryland
city: Boston
country: United States
facility: Vanda Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Vanda Investigational Site
state: Massachusetts
city: Chesterfield
country: United States
facility: Vanda Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Vanda Investigational Site
state: Nevada
city: Brooklyn
country: United States
facility: Vanda Investigational Site
state: New York
city: Charlotte
country: United States
facility: Vanda Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Vanda Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Vanda Investigational Site
state: Ohio
city: Huber Heights
country: United States
facility: Vanda Investigational Site
state: Ohio
city: Edmond
country: United States
facility: Vanda Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Vanda Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Vanda Investigational Site
state: Pennsylvania
city: Chattanooga
country: United States
facility: Vanda Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Vanda Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Vanda Investigational Site
state: Texas
city: Houston
country: United States
facility: Vanda Investigational Site
state: Texas
city: Plano
country: United States
facility: Vanda Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Vanda Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Vanda Investigational Site
state: Utah
Study officials:
affiliation: Vanda Pharmaceuticals
name: Vanda Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Carlin JL, Polymeropoulos C, Camilleri M, Lembo A, Fisher M, Kupersmith C, Madonick D, Moszczynski P, Smieszek S, Xiao C, Birznieks G, Polymeropoulos MH. The Efficacy of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Phase 3 Randomized Placebo-Controlled Clinical Trial. Clin Gastroenterol Hepatol. 2024 Dec;22(12):2506-2516. doi: 10.1016/j.cgh.2024.01.005. Epub 2024 Jan 17.