RecruitingPhase 3NCT06836557

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

Enrollment

100 participants

Start Date

Jan 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

  • Diagnosed with gastroparesis
  • Demonstrated delayed gastric emptying
  • Presence of moderate to severe nausea
  • Body Mass Index (BMI) of ≥18 and ≤40 kg/m2

Exclusion Criteria4

  • Another active disorder or treatment which could explain or contribute to symptoms of 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 or metabolic crisis in past 60 days)

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Interventions

DRUGTradipitant

BID


Locations(3)

Vanda Investigational Site

Leuven, Belgium

Vanda Investigational Site

Liège, Belgium

Vanda Investigational Site

Leipzig, Germany

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NCT06836557


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