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Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis

Primary Purpose

Idiopathic Gastroparesis, Diabetic Gastroparesis, Gastroparesis

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tradipitant
Placebo
Sponsored by
Vanda Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Gastroparesis focused on measuring gastroparesis, idiopathic, diabetic, tradipitant, nausea, vomiting, stomach, motility, functional, NK-1 antagonist, neurokinin 1 receptor, substance p

Eligibility Criteria

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

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

Sites / Locations

  • 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tradipitant

Placebo

Arm Description

Oral Capsule

Oral Capsule

Outcomes

Primary Outcome Measures

Change from baseline in daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary (GCS-DD)
A daily symptom diary asking patients to rate their nausea on a Likert scale from 0-5 (0=none, 5= very severe).

Secondary Outcome Measures

Change from baseline in other average core gastroparesis symptoms from the Gastroparesis Core Symptom Daily Diary
A patient reported daily symptom diary asking patients to rate their nausea on a Likert scale from 0-5 (0=none, 5= very severe). Other symptoms include vomiting, postprandial fullness, early satiety, and abdominal pain
Change from baseline in Patient Assessment of Gastrointestinal Disorders - Symptoms Severity Index (PAGI-SYM)
PAGI-SYM is a patient reported outcome that measures specific symptoms of patients with upper gastrointestinal disorders such as gastroparesis, GERD, and dyspepsia on a 0-5 Likert Scale (0=none, 5=very severe).
Change from baseline in Patient Global Impression - Change (PGI-C)
A patient reported outcome measuring a patient's rating of overall improvement after treatment on a 7 point scale that includes items "1=very much worse" and "7=very much improved"
Clinician Global Impression - Severity (CGI-S)
A clinician reported outcome that measures the clinician's view of the patient's global functioning prior to and after initiating treatment. Symptom severity is measured on a 7 point scale including "1=normal, not at all ill" and "7=among the most extremely ill patients."
Safety and tolerability as measured by spontaneous reporting of adverse events (AEs)
Safety will be monitored using clinical measures, vital signs, blood chemistry, hematology, urology, ECGs, and patient reported questionnaires.

Full Information

First Posted
July 10, 2019
Last Updated
September 28, 2023
Sponsor
Vanda Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04028492
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Gastroparesis, Diabetic Gastroparesis, Gastroparesis
Keywords
gastroparesis, idiopathic, diabetic, tradipitant, nausea, vomiting, stomach, motility, functional, NK-1 antagonist, neurokinin 1 receptor, substance p

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tradipitant
Arm Type
Experimental
Arm Description
Oral Capsule
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral Capsule
Intervention Type
Drug
Intervention Name(s)
Tradipitant
Intervention Description
BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
BID
Primary Outcome Measure Information:
Title
Change from baseline in daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary (GCS-DD)
Description
A daily symptom diary asking patients to rate their nausea on a Likert scale from 0-5 (0=none, 5= very severe).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in other average core gastroparesis symptoms from the Gastroparesis Core Symptom Daily Diary
Description
A patient reported daily symptom diary asking patients to rate their nausea on a Likert scale from 0-5 (0=none, 5= very severe). Other symptoms include vomiting, postprandial fullness, early satiety, and abdominal pain
Time Frame
12 weeks
Title
Change from baseline in Patient Assessment of Gastrointestinal Disorders - Symptoms Severity Index (PAGI-SYM)
Description
PAGI-SYM is a patient reported outcome that measures specific symptoms of patients with upper gastrointestinal disorders such as gastroparesis, GERD, and dyspepsia on a 0-5 Likert Scale (0=none, 5=very severe).
Time Frame
12 weeks
Title
Change from baseline in Patient Global Impression - Change (PGI-C)
Description
A patient reported outcome measuring a patient's rating of overall improvement after treatment on a 7 point scale that includes items "1=very much worse" and "7=very much improved"
Time Frame
12 weeks
Title
Clinician Global Impression - Severity (CGI-S)
Description
A clinician reported outcome that measures the clinician's view of the patient's global functioning prior to and after initiating treatment. Symptom severity is measured on a 7 point scale including "1=normal, not at all ill" and "7=among the most extremely ill patients."
Time Frame
12 weeks
Title
Safety and tolerability as measured by spontaneous reporting of adverse events (AEs)
Description
Safety will be monitored using clinical measures, vital signs, blood chemistry, hematology, urology, ECGs, and patient reported questionnaires.
Time Frame
12 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanda Pharmacuticals
Phone
202-734-3400
Email
clinicaltrials@vandapharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Organizational Affiliation
Vanda Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Vanda Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
53244
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
202-734-3400
Facility Name
Vanda Investigational Site
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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:
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:
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
202-734-3400
Facility Name
Vanda Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
202-734-3400
Facility Name
Vanda Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90026
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
202-734-3400
Facility Name
Vanda Investigational Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
202-734-3400
Facility Name
Vanda Investigational Site
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
202-734-3400
Facility Name
Vanda Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
202-734-3400
Facility Name
Vanda Investigational Site
City
Wauconda
State/Province
Illinois
ZIP/Postal Code
60084
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
202-734-3400
Facility Name
Vanda Investigational Site
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
202-734-3400
Facility Name
Vanda Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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:
Phone
303-734-3400
Facility Name
Vanda Investigational Site
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Contact:
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:
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:
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
202-734-3400
Facility Name
Vanda Investigational Site
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
202-734-3400
Facility Name
Vanda Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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:
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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:
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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:
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
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:
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:
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
202-734-3400
Facility Name
Vanda Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
202-734-3400
Facility Name
Vanda Investigational Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
202-734-3400
Facility Name
Vanda Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
202-734-3400
Facility Name
Vanda Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
202-734-3400

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.gpvandastudy.com
Description
Study Website

Learn more about this trial

Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis

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