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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2019 Phase 3 trial • 375 Patients • NCT035683314%
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
~1090
Find a Location
Who is running the clinical trial?
Xiao Jing (Iris) WangLead Sponsor
Vanda PharmaceuticalsLead Sponsor
62 Previous Clinical Trials
19,370 Total Patients Enrolled
Mayo ClinicOTHER
3,339 Previous Clinical Trials
3,062,112 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have other health conditions that could affect the study's outcome.
Research Study Groups:
This trial has the following groups:- Group 1: Tradipitant
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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