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Completed
NCT04028492
Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis
Conditions: Idiopathic Gastroparesis, Diabetic Gastroparesis, Gastroparesis
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 979
Sponsor: Vanda Pharmaceuticals
Location: Vanda Investigational Site Birmingham Alabama
Summary
To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of gastroparesis.
Eligibility 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
Source: ClinicalTrials.gov (NCT04028492). StuddyBuddy aggregates publicly available trial information.