Study to Assess the Efficacy of VLY-686 in Relieving Symptoms of Gastroparesis

Gastroparesis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02970968
• Other study ID #: VP-VLY-686-2301
• Status: Recruiting
• Phase: Phase 2
• First received: November 15, 2016
• Last updated: April 26, 2018
• Start date: November 2016
• Est. completion date: December 2018

Study information

• Verified date: April 2018
• Source: Vanda Pharmaceuticals
• Contact: Vanda Pharmaceuticals
• Phone: 202-734-3400
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Drug:
• VLY-686 (Tradipitant)
oral capsule

Other:
• Placebo
placebo oral

Locations

Country	Name	City	State
United States	Vanda Investigational Site	Athens	Georgia
United States	Vanda Investigational Site	Boston	Massachusetts
United States	Vanda Investigational Site	Boston	Massachusetts
United States	Vanda Investigational Site	Chattanooga	Tennessee
United States	Vanda Investigational Site	Chevy Chase	Maryland
United States	Vanda Investigational Site	Chula Vista	California
United States	Vanda Investigational Site	Dothan	Alabama
United States	Vanda Investigational Site	El Paso	Texas
United States	Vanda Investigational Site	Elgin	Illinois
United States	Vanda Investigational Site	Great Neck	New York
United States	Vanda Investigational Site	Houston	Texas
United States	Vanda Investigational Site	Huber Heights	Ohio
United States	Vanda Investigational Site	Huntsville	Alabama
United States	Vanda Investigational Site	Indianapolis	Indiana
United States	Vanda Investigational Site	Jackson	Tennessee
United States	Vanda Investigational Site	Jacksonville	Florida
United States	Vanda Investigational Site	Largo	Florida
United States	Vanda Investigational Site	Little Rock	Arkansas
United States	Vanda Investigational Site	Los Angeles	California
United States	Vanda Investigational Site	Louisville	Kentucky
United States	Vanda Investigational Site	Marrero	Louisiana
United States	Vanda Investigational Site	Mentor	Ohio
United States	Vanda Investigational Site	Miami	Florida
United States	Vanda Investigational Site	Minneapolis	Minnesota
United States	Vanda Investigational Site	Nashville	Tennessee
United States	Vanda Investigational Site	New York	New York
United States	Vanda Investigational Site	Norfolk	Virginia
United States	Vanda Investigational Site	Palo Alto	California
United States	Vanda Investigational Site	Pascagoula	Mississippi
United States	Vanda Investigational Site	Philadelphia	Pennsylvania
United States	Vanda Investigational Site	Raleigh	North Carolina
United States	Vanda Investigational Site	Richardson	Texas
United States	Vanda Investigational Site	Saint Louis	Missouri
United States	Vanda Investigational Site	Salisbury	North Carolina
United States	Vanda Investigational Site	San Francisco	California
United States	Vanda Investigational Site	Tucson	Arizona
United States	Vanda Investigational Site	Tulsa	Oklahoma
United States	Vanda Investigational Site	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gastroparesis associated symptoms as assessed by patient reported diary		4 weeks