NCT05653310

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
7mo left

Started Feb 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Feb 2023Mar 2027

First Submitted

Initial submission to the registry

April 29, 2022

Completed
8 months until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 9, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

4.1 years

First QC Date

April 29, 2022

Last Update Submit

July 15, 2026

Conditions

Functional Dyspepsia

Keywords

tradipitantNK-1 antagonistneurokinin 1 receptor

Outcome Measures

Primary Outcomes (1)

  • Accommodation gastric volumes measured by single photon emission computed tomography (SPECT)

    4 Weeks

Study Arms (2)

Tradipitant

EXPERIMENTAL

Oral Capsule

Drug: Tradipitant

Placebo

PLACEBO COMPARATOR

Oral Capsule

Drug: Placebo

Interventions

TradipitantDRUG

Tradipitant Capsule

Tradipitant
PlaceboDRUG

Placebo Capsule

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Current H. pylori infection
  • Pregnancy or nursing
  • Recent history of Alcohol Use Disorder or Substance Use Disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Links

Study Officials

  • Xiao Jing (Iris) Wang, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Regulatory Sponsor and Principal Investigator

Study Record Dates

First Submitted

April 29, 2022

First Posted

December 16, 2022

Study Start

February 9, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)