Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis

Vanda Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Diabetic Gastroparesis; Gastroparesis; Idiopathic Gastroparesis

Treatments: Drug: Tradipitant

Study type: Interventional

Funder types: Industry

Identifiers

NCT06836557

VP-VLY-686-3304

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

Open Label Tradipitant

Experimental group

Description:

Oral Capsule

Treatment:

Drug: Tradipitant