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A MULTICENTER OPEN LABEL 3 MONTH SAFETY STUDY WITH TRADIPITANT IN PATIENTS WITH IDIOPATHIC OR DIABETIC GASTROPARESIS

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503802-35-00
Acronym
VP-VLY-686-3304
Enrollment
70
Registered
2024-12-03
Start date
2023-11-29
Completion date
Unknown
Last updated
2025-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic or diabetic gastroparesis with moderate to severe nausea.

Brief summary

To evaluate dosing of tradipitant on standard measures of subject safety by assessing adverse events (AEs) including suicidal ideation or behavior, changes in vital signs, clinical laboratory evaluations, electrocardiograms (ECGs) and physical exam findings during treatment.

Interventions

Sponsors

Vanda Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
To evaluate dosing of tradipitant on standard measures of subject safety by assessing adverse events (AEs) including suicidal ideation or behavior, changes in vital signs, clinical laboratory evaluations, electrocardiograms (ECGs) and physical exam findings during treatment.

Countries

Belgium, Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026