Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis
← catalyst calendarSponsored by Vanda Pharmaceuticals (industry) · VNDA — their whole pipeline →.
Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
992actual
Sites
36
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-08-20 | actual | When the study began enrolling |
| Primary completion | 2025-02-21 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-02-21 | actual | The whole study's end, after follow-up |
| First posted | 2019-07-22 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-07-24 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Idiopathic Gastroparesis
- Diabetic Gastroparesis
- Gastroparesis
Interventions
- Drug: Tradipitant
- Drug: Placebo
- Drug: Open Label Tradipitant
Primary outcome
what the primary-completion date above is the date OFChange from baseline in daily average nausea severity scores from the Gastroparesis Core Symptom Daily Diary (GCS-DD)
measured 12 weeks
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2022-10-27 · 541 KB · Prot_000.pdf
Statistical Analysis Planposted 2022-10-27 · 296 KB · SAP_001.pdf
Publications
- PMID 38237696 — reports results
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
Permalink · VNDA's whole pipeline · Catalyst calendar · Every registered study · What changed