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)
View Full Details on ClinicalTrials.gov
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NCT06836557
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