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 range18 Years – 70 Years

SexALL

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)

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