Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis
Primary Purpose
Gastroparesis, Diabetic Gastroparesis
Status
Available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Tradipitant
Sponsored by
About this trial
This is an expanded access trial for Gastroparesis focused on measuring gastroparesis, idiopathic, diabetic, tradipitant, nausea, vomiting, stomach, motility, functional, NK-1 antagonist, neurokinin 1 receptor, substance p, expanded access
Eligibility Criteria
Inclusion Criteria:
- Identified subject who requested expanded access
- Diagnosed with gastroparesis
- Demonstrated delayed gastric emptying
- Presence of moderate to severe nausea
- Patient does not qualify for or does not have access to other clinical trials with tradipitant;
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 other than tradipitant
- Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year
- Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit ratio to treatment;
Sites / Locations
- Vanda Investigational Site
- Vanda Investigational Site
- Vanda Investigational Site
- Vanda Investigational Site
- Vanda Investigational Site
- Vanda Investigational Site
- Vanda Investigational Site
- Vanda Investigational Site
- Vanda Investigational Site
- Vanda Investigational Site
- Vanda Investigational Site
- Vanda Investigational Site
- Vanda Investigational Site
- Vanda Investigational Site
- Vanda Investigational Site
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT04474990
First Posted
July 13, 2020
Last Updated
September 29, 2023
Sponsor
Vanda Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT04474990
Brief Title
Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis
Official Title
VP-VLY-686-3303: Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis
Study Type
Expanded Access
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanda Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
Primary Objective: To treat a single patient with gastroparesis who has requested expanded access with tradipitant
Detailed Description
This is a single-patient extended access treatment protocol to be conducted in the United States. Investigator-Physician has determined patient satisfies expanded access inclusion criteria and has requested expanded access to tradipitant.
Patient will be given open label tradipitant 85 mg to be taken twice daily at 12 hour intervals for long term treatment. Patient can fill out daily web-based symptom diaries on a voluntary basis and report any adverse events to Investigator-Physician.
Primary Objective:
-To treat a single patient with gastroparesis who has requested expanded access with tradipitant
Secondary Objectives:
To monitor the efficacy of tradipitant in reducing individual symptoms associated with gastroparesis in this single patient
To monitor the safety of tradipitant in a patient with gastroparesis by assessing adverse events in this single patient
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis, Diabetic Gastroparesis
Keywords
gastroparesis, idiopathic, diabetic, tradipitant, nausea, vomiting, stomach, motility, functional, NK-1 antagonist, neurokinin 1 receptor, substance p, expanded access
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tradipitant
Intervention Description
NK-1 Receptor antagonist
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Eligibility Criteria
Inclusion Criteria:
Identified subject who requested expanded access
Diagnosed with gastroparesis
Demonstrated delayed gastric emptying
Presence of moderate to severe nausea
Patient does not qualify for or does not have access to other clinical trials with tradipitant;
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 other than tradipitant
Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year
Any other reason as determined by the Investigator which may lead to an unfavorable risk-benefit ratio to treatment;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanda Pharmaceuticals
Phone
2027343400
Email
clinicaltrials@vandapharma.com
Facility Information:
Facility Name
Vanda Investigational Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Wauconda
State/Province
Illinois
ZIP/Postal Code
60084
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Available
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
Available
Facility Contact:
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Individual Site Status
Available
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
Available
Facility Contact:
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Available
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
Available
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
Available
Facility Contact:
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Available
Facility Contact:
Phone
202-734-3400
12. IPD Sharing Statement
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Single-Patient Expanded Access Protocol for Tradipitant In A Single Patient With Gastroparesis
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