Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of gastroparesis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanda Pharmaceuticals

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