Tradipitant for Functional Dyspepsia

NCT ID: NCT05653310

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-09

Study Completion Date

2026-06-30

Brief Summary

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To evaluate the effects of tradipitant relative to placebo on gastric motor functions, satiation, and postprandial symptoms in patients with functional dyspepsia.

Detailed Description

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Conditions

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Functional Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tradipitant

Oral Capsule

Group Type EXPERIMENTAL

Tradipitant

Intervention Type DRUG

Tradipitant Capsule

Placebo

Oral Capsule

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Capsule

Interventions

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Tradipitant

Tradipitant Capsule

Intervention Type DRUG

Placebo

Placebo Capsule

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role collaborator

Xiao Jing (Iris) Wang

OTHER

Sponsor Role lead

Responsible Party

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Xiao Jing (Iris) Wang

Regulatory Sponsor and Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xiao Jing (Iris) Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Minnesota

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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21-012527

Identifier Type: -

Identifier Source: org_study_id

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