Status:
COMPLETED
Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis
Lead Sponsor:
Vanda Pharmaceuticals
Conditions:
Idiopathic Gastroparesis
Diabetic Gastroparesis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of gastroparesis.
Eligibility Criteria
Inclusion
- Diagnosed with gastroparesis
- Demonstrated delayed gastric emptying
- Presence of moderate to severe nausea
- Body Mass Index (BMI) of ≥18 and ≤40 kg/m2
Exclusion
- 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
Key Trial Info
Start Date :
August 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2025
Estimated Enrollment :
992 Patients enrolled
Trial Details
Trial ID
NCT04028492
Start Date
August 20 2019
End Date
February 21 2025
Last Update
July 24 2025
Active Locations (36)
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1
Vanda Investigational Site
Birmingham, Alabama, United States, 53244
2
Vanda Investigational Site
Peoria, Arizona, United States, 85381
3
Vanda Investigational Site
Little Rock, Arkansas, United States, 72211
4
Vanda Investigational Site
Chula Vista, California, United States, 91910