Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis

Sponsor
Vanda Pharmaceuticals
Study ID
NCT06836557
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Diabetic Gastroparesis
  • Gastroparesis
  • Idiopathic Gastroparesis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Tradipitant — DRUG
    BID

Study Details

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

Key Dates

First listed
Feb 20, 2025
Start date
Jan 9, 2024
Status verified
Feb 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open Label Tradipitant
    Oral Capsule

Primary Outcome Measure

Number of participants with adverse events (AEs), including suicidal ideation or behavior as measured by the C-SSRS [ Time Frame: 12 weeks ]

Central Contacts

Related Studies