Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis

Launched by VANDA PHARMACEUTICALS · Feb 14, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called tradipitant for people with gastroparesis, a condition where the stomach takes too long to empty its contents. The study will last for three months and aims to assess the safety of tradipitant in patients who have either idiopathic gastroparesis (where the cause is unknown) or diabetic gastroparesis (related to diabetes). It is currently recruiting participants aged between 18 and 75, who are experiencing symptoms like moderate to severe nausea and have been diagnosed with gastroparesis.

To be eligible, participants must have confirmed delayed gastric emptying and a body mass index (BMI) between 18 and 40. However, those with other health issues that might explain their symptoms, women who are pregnant or nursing, or individuals with uncontrolled blood sugar levels are not eligible to join the study. Participants in this trial can expect to receive the investigational treatment and will be closely monitored for any side effects during the study period. This trial is an important step in finding new ways to help manage gastroparesis symptoms effectively.

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
• • Pregnancy or nursing
• • Evidence of uncontrolled blood glucose (including HbA1C \>11% at screening or metabolic crisis in past 60 days)