Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis
Purpose
To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of gastroparesis.
Conditions
- Idiopathic Gastroparesis
- Diabetic Gastroparesis
- Gastroparesis
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Tradipitant |
Oral Capsule |
|
|
Placebo Comparator Placebo |
Oral Capsule |
|
|
Experimental Open Label Tradipitant |
Oral Capsule |
|
Recruiting Locations
More Details
- NCT ID
- NCT04028492
- Status
- Completed
- Sponsor
- Vanda Pharmaceuticals