Pharmacodynamics, Pharmacogenetics, Clinical Efficacy and Safety of Tradipitant for Functional Dyspepsia
Primary Purpose
Functional Dyspepsia
Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tradipitant
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Functional Dyspepsia focused on measuring tradipitant, NK-1 antagonist, neurokinin 1 receptor
Eligibility Criteria
Inclusion Criteria: Able to provide written consent Body Mass Index (BMI) of 18-35 kg/m2 Absence of other diseases which could interfere with interpretation of study results Exclusion Criteria: Current H. pylori infection Pregnancy or nursing Recent history of Alcohol Use Disorder or Substance Use Disorder
Sites / Locations
- Vanda Investigational Site
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
Accommodation gastric volumes measured by single photon emission computed tomography (SPECT)
Secondary Outcome Measures
Full Information
NCT ID
NCT05653310
First Posted
April 29, 2022
Last Updated
December 7, 2022
Sponsor
Vanda Pharmaceuticals
Collaborators
Mayo Clinic
1. Study Identification
Unique Protocol Identification Number
NCT05653310
Brief Title
Pharmacodynamics, Pharmacogenetics, Clinical Efficacy and Safety of Tradipitant for Functional Dyspepsia
Official Title
Pharmacodynamics, Pharmacogenetics, Clinical Efficacy and Safety of Tradipitant for Functional Dyspepsia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanda Pharmaceuticals
Collaborators
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the effects of tradipitant relative to placebo on gastric motor functions, satiation, and postprandial symptoms in patients with functional dyspepsia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
Keywords
tradipitant, NK-1 antagonist, neurokinin 1 receptor
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (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
Tradipitant Capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Capsule
Primary Outcome Measure Information:
Title
Accommodation gastric volumes measured by single photon emission computed tomography (SPECT)
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:
Able to provide written consent
Body Mass Index (BMI) of 18-35 kg/m2
Absence of other diseases which could interfere with interpretation of study results
Exclusion Criteria:
Current H. pylori infection
Pregnancy or nursing
Recent history of Alcohol Use Disorder or Substance Use Disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanda Pharmaceuticals
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
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
202-734-3400
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pharmacodynamics, Pharmacogenetics, Clinical Efficacy and Safety of Tradipitant for Functional Dyspepsia
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