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

Primary Purpose

Gastroparesis

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VLY-686 (Tradipitant)
Placebo
Sponsored by
Vanda Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroparesis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
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  • Vanda Investigational SiteRecruiting
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  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting
  • Vanda Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study Drug

Placebo

Arm Description

VLY-686 (Tradipitant) oral capsule for 4 weeks.

Placebo oral capsule for 4 weeks.

Outcomes

Primary Outcome Measures

Change in gastroparesis associated symptoms as assessed by patient reported diary

Secondary Outcome Measures

Full Information

First Posted
November 15, 2016
Last Updated
April 26, 2018
Sponsor
Vanda Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02970968
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanda Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Drug
Arm Type
Experimental
Arm Description
VLY-686 (Tradipitant) oral capsule for 4 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo oral capsule for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
VLY-686 (Tradipitant)
Intervention Description
oral capsule
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo oral
Primary Outcome Measure Information:
Title
Change in gastroparesis associated symptoms as assessed by patient reported diary
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with gastroparesis; Subjects must agree to the use of contraception Ability and acceptance to provide written informed consent; Willing to participate in the pharmacogenomics sample collection; Willing and able to comply with all study requirements and restrictions Willing to not participate in any other interventional trial for the duration of their participation. Exclusion Criteria: 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); Pregnancy or nursing; History of intolerance and/or hypersensitivity to medications similar to VLY-686 (Tradipitant) and its accompanying excipients; Use of another NK1 antagonist or palonosetron; Exposure to any investigational medication, including placebo, within 60 days of the Baseline Visit; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Information:
Facility Name
Vanda Investigational Site
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Largo
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Elgin
State/Province
Illinois
ZIP/Postal Code
60123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Pascagoula
State/Province
Mississippi
ZIP/Postal Code
39564
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Huber Heights
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Richardson
State/Province
Texas
ZIP/Postal Code
75082
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32693185
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.
Results Reference
derived

Learn more about this trial

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

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