GASTROPARESIS

TITLE: A multicenter, randomized, double-blind, placebo-controlled phase III study to assess the efficacy of tradipitant in relieving symptoms of gastroparesis

SPONSOR: Vanda

Primary Investigator: Dr. Ahuja

CONTACT: Lilly Hennessey lilly@hennessey@pennmedicine.upenn.edu

Criteria

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
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