Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis

Vanda Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Diabetic Gastroparesis; Gastroparesis; Idiopathic Gastroparesis

Treatments: Drug: Placebo; Drug: Tradipitant; Drug: Open Label Tradipitant

Study type: Interventional

Funder types: Industry

Identifiers

NCT04028492

VP-VLY-686-3301

Details and patient eligibility

About

To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of gastroparesis.

Enrollment: 201 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;
• Exposure to any investigational medication in the past 60 days
• Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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201 participants in 3 patient groups, including a placebo group

Tradipitant

Experimental group

Description:

Oral Capsule

Treatment:

Drug: Tradipitant

Placebo

Placebo Comparator group

Description:

Oral Capsule

Treatment:

Drug: Placebo

Open Label Tradipitant

Experimental group

Description:

Oral Capsule

Treatment:

Drug: Open Label Tradipitant