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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 4 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

2016

Completed Phase 3

~1150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Xiao Jing (Iris) WangLead Sponsor

Vanda PharmaceuticalsLead Sponsor

61 Previous Clinical Trials

19,341 Total Patients Enrolled

Mayo ClinicOTHER

3,205 Previous Clinical Trials

3,766,724 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include participants over the age of 80?

"This trial's enrolment criteria stipulates that participants must be aged 18 to 70. Additionally, 5 studies are available for minors and 20 trials have been designed with elderly individuals in mind."

Answered by AI

Are there still opportunities to volunteer for the study?

"Clinicaltrials.gov reveals that recruitment for this specific trial ended on December 7th 2022, as it was initially published on the 1st of December. However, 26 other studies are still actively searching for participants at present."

Answered by AI

Has the FDA given Tradipitant its seal of approval?

"As Tradipitant has not yet been clinically demonstrated to be efficacious, our team assigned it a safety rating of 2 on the 1-3 scale. Data still exists that implies its safety profile is acceptable for clinical use."

Answered by AI

What criteria must a person meet in order to participate in this research?

"This clinical trial requires 60 volunteers aged 18 to 70 that suffer from functional dyspepsia. To be considered, they must have no other conditions which could impede the interpretation of results, sign a consent form, and have a Body Mass Index between 18-35 kg/m2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tradipitant for Functional Dyspepsia

Xiao Jing (Iris) Wang 2023. "Tradipitant for Functional Dyspepsia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05653310.

All > Dyspepsia