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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.
Eligible Conditions
- Gastroparesis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
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 moreSide 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
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Vanda PharmaceuticalsLead Sponsor
62 Previous Clinical Trials
19,180 Total Patients Enrolled
2 Trials studying Gastroparesis
152 Patients Enrolled for Gastroparesis
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