Clinical trial NCT02970968: Study to Assess the Efficacy of VLY-686 in Relieving Symptoms of Gastroparesis
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Efficacy of VLY-686 (Tradipitant) in Relieving Symptoms of Gastroparesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastroparesis
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-11-22
Enrollment: 152
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: This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States. One hundred fifty (150) subjects diagnosed with gastroparesis, who satisfy the selection criteria for the study, will be randomized to one of two treatment groups, active or placebo.

Detailed description: This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States. One hundred fifty (150) subjects diagnosed with gastroparesis, who satisfy the selection criteria for the study, will be randomized to one of two treatment groups, active or placebo.

The study is divided into two phases: the screening phase and the evaluation phase. The screening phase includes a screening visit to evaluate subjects' preliminary eligibility for the study. During the screening phase, subjects will collect diary data for at least 4 weeks. The evaluation phase includes 4 weeks of randomized double-blind treatment.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with gastroparesis;
2. Subjects must agree to the use of contraception
3. Ability and acceptance to provide written informed consent;
4. Willing to participate in the pharmacogenomics sample collection;
5. Willing and able to comply with all study requirements and restrictions
6. Willing to not participate in any other interventional trial for the duration of their participation.

Exclusion Criteria:

1. Another active disorder or treatment which could explain or contribute to symptoms in the opinion of the Investigator (including but not limited to gastric malignancy, neurological disorder, or heavy doses of strong anticholinergics);
2. Pregnancy or nursing;
3. History of intolerance and/or hypersensitivity to medications similar to VLY-686 (Tradipitant) and its accompanying excipients;
4. Use of another NK1 antagonist or palonosetron;
5. Exposure to any investigational medication, including placebo, within 60 days of the Baseline Visit;
6. Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance, or may confound study results.

Primary outcomes:
measure: Change From Baseline in Average Nausea Severity
timeFrame: 4 weeks
Secondary outcomes:
measure: Weekly % Nausea-Free Days
timeFrame: 4 weeks
measure: Daily Average Vomiting Frequency, Change From Baseline
timeFrame: 4 weeks
measure: Gastroparesis Cardinal Symptom Index (GCSI), Change From Baseline
timeFrame: 4 weeks
measure: PAGI-SYM, Change From Baseline
timeFrame: 4 weeks
measure: CGI-S, Change From Baseline
timeFrame: 4 weeks
measure: PGI-C
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Vanda Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: Vanda Investigational Site
state: Alabama
city: Tucson
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: Los Angeles
country: United States
facility: Vanda Investigational Site
state: California
city: Palo Alto
country: United States
facility: Vanda Investigational Site
state: California
city: San Francisco
country: United States
facility: Vanda Investigational Site
state: California
city: Jacksonville
country: United States
facility: Vanda Investigational Site
state: Florida
city: Largo
country: United States
facility: Vanda Investigational Site
state: Florida
city: Miami
country: United States
facility: Vanda Investigational Site
state: Florida
city: Athens
country: United States
facility: Vanda Investigational Site
state: Georgia
city: Elgin
country: United States
facility: Vanda Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Vanda Investigational Site
state: Indiana
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: Wyoming
country: United States
facility: Vanda Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: Vanda Investigational Site
state: Minnesota
city: Pascagoula
country: United States
facility: Vanda Investigational Site
state: Mississippi
city: Saint Louis
country: United States
facility: Vanda Investigational Site
state: Missouri
city: Great Neck
country: United States
facility: Vanda Investigational Site
state: New York
city: New York
country: United States
facility: Vanda Investigational Site
state: New York
city: Raleigh
country: United States
facility: Vanda Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: Vanda Investigational Site
state: North Carolina
city: Huber Heights
country: United States
facility: Vanda Investigational Site
state: Ohio
city: Mentor
country: United States
facility: Vanda Investigational Site
state: Ohio
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: Jackson
country: United States
facility: Vanda Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Vanda Investigational Site
state: Tennessee
city: El Paso
country: United States
facility: Vanda Investigational Site
state: Texas
city: Houston
country: United States
facility: Vanda Investigational Site
state: Texas
city: Richardson
country: United States
facility: Vanda Investigational Site
state: Texas
city: Norfolk
country: United States
facility: Vanda Investigational Site
state: Virginia
Study officials:
References:
citation: Carlin JL, Lieberman VR, Dahal A, Keefe MS, Xiao C, Birznieks G, Abell TL, Lembo A, Parkman HP, Polymeropoulos MH. Efficacy and Safety of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial. Gastroenterology. 2021 Jan;160(1):76-87.e4. doi: 10.1053/j.gastro.2020.07.029. Epub 2020 Jul 18.