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Phase 3Completed

Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis

A Multicenter, Open Label, 3-Month Safety Study With Tradipitant in Patients With Idiopathic or Diabetic Gastroparesis

Sponsor
Vanda Pharmaceuticals (Industry)
Enrollment
17 enrolled
Conditions
Idiopathic Gastroparesis; Diabetic Gastroparesis; Gastroparesis
Interventions
Tradipitant
Ages
adults, older adults
Registry
NCT06836557

Full record on ClinicalTrials.gov

From the registry

This is a multicenter, open label, 3-month safety study with tradipitant in patients with idiopathic and diabetic gastroparesis.

Primary outcomes

  • Number of participants with adverse events (AEs), including suicidal ideation or behavior as measured by the C-SSRS
  • Number of participants with changes in vital signs identified as Clinically Notable Abnormal values
  • Number of participants with abnormal and potentially Clinically Notable Abnormal Electrocardiogram Intervals and Heart Rate
  • Number of participants with Clinically Notable Abnormal laboratory values

History

  1. Last registry update

  2. Primary completion

  3. Registered

  4. Started