RecruitingPhase 3

Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis

Belgium, Germany100 participantsStarted 2024-01-09

Plain-language summary

This is a multicenter, open label, 3-month safety study with tradipitant in patients with idiopathic and diabetic gastroparesis.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with adverse events (AEs), including suicidal ideation or behavior as measured by the C-SSRS

Timeframe: 12 weeks

Number of participants with changes in vital signs identified as Clinically Notable Abnormal values

Timeframe: 12 weeks

Number of participants with abnormal and potentially Clinically Notable Abnormal Electrocardiogram Intervals and Heart Rate

Timeframe: 12 weeks

Number of participants with Clinically Notable Abnormal laboratory values

Timeframe: 12 weeks

Trial details

NCT IDNCT06836557

SponsorVanda Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Vanda Pharmaceuticals

202-734-3400 clinicaltrials@vandapharma.com

View on ClinicalTrials.gov More Idiopathic Gastroparesis trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants with adverse events (AEs), including suicidal ideation or behavior as measured by the C-SSRS

Timeframe: 12 weeks

Number of participants with changes in vital signs identified as Clinically Notable Abnormal values

Timeframe: 12 weeks

Number of participants with abnormal and potentially Clinically Notable Abnormal Electrocardiogram Intervals and Heart Rate

Timeframe: 12 weeks

Number of participants with Clinically Notable Abnormal laboratory values

Timeframe: 12 weeks