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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
Vanda Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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

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

First Posted
April 29, 2022
Last Updated
December 7, 2022
Sponsor
Vanda Pharmaceuticals
Collaborators
Mayo Clinic
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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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