Safety evaluation of Tradipitant for treating gastroparesis
A Multicenter, Open Label, 3-Month Safety Study with Tradipitant in Patients with Idiopathic or Diabetic Gastroparesis
This study is testing if Tradipitant is safe for people with gastroparesis, especially those dealing with nausea, over three months.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Vanda Pharmaceuticals Industry-sponsored |
| Locations | 3 sites (Leuven and 2 other locations) |
| Trial ID | NCT06836557 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label study investigates the safety of Tradipitant in patients diagnosed with idiopathic and diabetic gastroparesis over a period of three months. Participants will be monitored for their symptoms, particularly focusing on nausea and gastric emptying. The study aims to gather data on the tolerability and safety profile of Tradipitant in this patient population. By including patients with moderate to severe nausea, the study seeks to address a significant unmet need in managing gastroparesis.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with idiopathic or diabetic gastroparesis who experience moderate to severe nausea.
Not a fit: Patients with other active disorders that could explain their symptoms or those with uncontrolled blood glucose levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from gastroparesis, potentially improving their quality of life.
How similar studies have performed: While this approach is focused on Tradipitant, similar studies targeting gastroparesis have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Leuven and 2 other locations
- Vanda Investigational Site — Leuven, Belgium (Recruiting)
- Vanda Investigational Site — Liège, Belgium (Recruiting)
- Vanda Investigational Site — Leipzig, Germany (Recruiting)
Study contacts
- Study coordinator: Vanda Pharmaceuticals
- Email: clinicaltrials@vandapharma.com
- Phone: 202-734-3400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.