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

Launched by VANDA PHARMACEUTICALS · Jul 18, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a medication called tradipitant to see if it can help relieve nausea and other symptoms in people with gastroparesis, which is a condition that affects how the stomach empties. The trial is specifically looking at individuals with idiopathic (unknown cause) and diabetic gastroparesis. It aims to determine if tradipitant is more effective than a placebo, which is an inactive treatment that looks like the real medication.

To be eligible for this trial, participants must be diagnosed with gastroparesis and have symptoms like moderate to severe nausea. They should also have a Body Mass Index (BMI) between 18 and 40, which is a measure of body weight in relation to height. Importantly, people with other active health issues that could affect their gastroparesis symptoms, or who have had certain types of stomach surgery recently, won’t be able to participate. Those who join the trial can expect regular visits for assessments and to receive either the study medication or a placebo over the course of the study. The trial is currently recruiting participants aged 18 to 75, and both men and women are welcome to join.

Gender

ALL

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