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Tradipitant for Gastroparesis

Phase 3
Recruiting
Research Sponsored by Vanda Pharmaceuticals
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 12 weeks
Awards & highlights
Pivotal Trial

Summary

This trial is testing tradipitant, a medication that may help reduce nausea and other symptoms in people with gastroparesis. It targets patients whose symptoms are not well managed by current treatments. The medication works by stopping the brain from sending messages that make you feel sick.

Who is the study for?
This trial is for individuals with gastroparesis, a condition that slows or stops the movement of food from the stomach to the small intestine. Participants must have moderate to severe nausea and a BMI between 18 and 40. Those who've used drugs of abuse recently, taken investigational meds in the last 60 days, or had certain stomach surgeries can't join.
What is being tested?
The study aims to compare Tradipitant, an experimental medication, against a placebo (a substance with no active drug) to see if it's safe and effective at reducing nausea and other symptoms associated with gastroparesis.
What are the potential side effects?
While specific side effects are not listed here, Tradipitant could potentially cause reactions similar to other medications in its class such as headaches, dizziness, dry mouth or fatigue. Placebo typically has no side effects but may result in minor reactions due to psychological factors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary (GCS-DD)
Secondary study objectives
Change from baseline in Patient Assessment of Gastrointestinal Disorders - Symptoms Severity Index (PAGI-SYM)
Change from baseline in Patient Global Impression - Change (PGI-C)
Change from baseline in other average core gastroparesis symptoms from the Gastroparesis Core Symptom Daily Diary
+2 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: TradipitantExperimental Treatment1 Intervention
Oral Capsule
Group II: Open Label TradipitantExperimental Treatment1 Intervention
Oral Capsule
Group III: PlaceboPlacebo Group1 Intervention
Oral Capsule
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tradipitant
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Vanda PharmaceuticalsLead Sponsor
63 Previous Clinical Trials
19,026 Total Patients Enrolled
2 Trials studying Gastroparesis
152 Patients Enrolled for Gastroparesis
~32 spots leftby Dec 2025
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