Recruiting NCT06836557
Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tradipitant.
- Who it may be relevant to
- Registry conditions: Idiopathic Gastroparesis, Diabetic Gastroparesis, Gastroparesis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Open Label, 3-Month Safety Study with Tradipitant in Patients with Idiopathic or Diabetic Gastroparesis
Overview
This is a multicenter, open label, 3-month safety study with tradipitant in patients with idiopathic and diabetic gastroparesis.
Interventions
- Drug Tradipitant
BID
Primary outcome measures
- Number of participants with adverse events (AEs), including suicidal ideation or behavior as measured by the C-SSRS [Time frame: 12 weeks]
- Number of participants with changes in vital signs identified as Clinically Notable Abnormal values [Time frame: 12 weeks]
- Number of participants with abnormal and potentially Clinically Notable Abnormal Electrocardiogram Intervals and Heart Rate [Time frame: 12 weeks]
- Number of participants with Clinically Notable Abnormal laboratory values [Time frame: 12 weeks]
Secondary outcome measures (2)
- To evaluate the efficacy of tradipitant in reducing individual symptoms associated with gastroparesis [Time frame: 12 weeks]
- To evaluate the efficacy of tradipitant in global improvement [Time frame: 12 weeks]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 2 centers
- Vanda Investigational Site — Leuven
- Vanda Investigational Site — Liège
Germany · 1 center
- Vanda Investigational Site — Leipzig
Identifiers
NCT: NCT06836557 · VP-VLY-686-3304