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Neurokinin-1 Receptor Antagonist

Tradipitant for Indigestion

Phase 2
Waitlist Available
Led By Xiao Jing (Iris) Wang, MD
Research Sponsored by Xiao Jing (Iris) Wang
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial tests how a drug affects stomach functions, feeling full, and post-meal symptoms in people with stomach issues.

Who is the study for?
This trial is for adults with a BMI of 18-35 who suffer from functional dyspepsia, commonly known as indigestion. Participants must be able to consent and not have other conditions that could affect the study's results. Those with recent alcohol or substance use disorders, current H. pylori infection, or who are pregnant or nursing cannot join.
What is being tested?
The trial is testing Tradipitant against a placebo to see if it improves gastric functions and reduces symptoms like feeling full quickly (satiation) and discomfort after eating in people with indigestion.
What are the potential side effects?
Potential side effects of Tradipitant may include drowsiness, dry mouth, fatigue, and nausea. Since some participants will receive a placebo instead of the actual medication, they might not experience any drug-related side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2019 Phase 3 trial • 375 Patients • NCT03568331
4%
Upper respiratory tract infection
4%
Headache
3%
Diarrhoea
2%
Dermatitis atopic
1%
Choking
1%
Dyshidrotic eczema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tradipitant
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TradipitantExperimental Treatment1 Intervention
Oral Capsule
Group II: PlaceboPlacebo Group1 Intervention
Oral Capsule
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tradipitant
2021
Completed Phase 3
~1410

Find a Location

Who is running the clinical trial?

Xiao Jing (Iris) WangLead Sponsor
Vanda PharmaceuticalsLead Sponsor
63 Previous Clinical Trials
19,167 Total Patients Enrolled
Mayo ClinicOTHER
3,353 Previous Clinical Trials
3,060,963 Total Patients Enrolled
Xiao Jing (Iris) Wang, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
25 Total Patients Enrolled

Media Library

Tradipitant (Neurokinin-1 Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05653310 — Phase 2
Indigestion Research Study Groups: Tradipitant, Placebo
Indigestion Clinical Trial 2023: Tradipitant Highlights & Side Effects. Trial Name: NCT05653310 — Phase 2
Tradipitant (Neurokinin-1 Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05653310 — Phase 2
~20 spots leftby Dec 2025
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