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