Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis

Last updated: February 14, 2025
Sponsor: Vanda Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetic Gastroparesis

Gastroparesis

Treatment

Tradipitant

Clinical Study ID

NCT06836557
VP-VLY-686-3304
  • Ages 18-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with gastroparesis

  • Demonstrated delayed gastric emptying

  • Presence of moderate to severe nausea

  • Body Mass Index (BMI) of ≥18 and ≤40 kg/m2

Exclusion

Exclusion Criteria:

  • Another active disorder or treatment which could explain or contribute to symptomsof gastroparesis

  • A positive test for drugs of abuse at the screening or evaluation visits

  • Pregnancy or nursing

  • Evidence of uncontrolled blood glucose (including HbA1C >11% at screening ormetabolic crisis in past 60 days)

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Tradipitant
Phase: 3
Study Start date:
January 09, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Vanda Investigational Site

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Vanda Investigational Site

    Liège, 4000
    Belgium

    Active - Recruiting

  • Vanda Investigational Site

    Leipzig, 04103
    Germany

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.