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Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis

NCT04028492 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 992

Last updated 2025-07-24

No results posted yet for this study

Summary

To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of gastroparesis.

Conditions

Interventions

DRUG

Tradipitant

BID

DRUG

Placebo

BID

DRUG

Open Label Tradipitant

BID

Sponsors & Collaborators

Principal Investigators

  • Vanda Pharmaceuticals · Vanda Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-20
Primary Completion
2025-02-21
Completion
2025-02-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04028492 on ClinicalTrials.gov