Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorVanda Pharmaceuticals
About this trial
This is a multicenter, open label, 3-month safety study with tradipitant in patients with idiopathic and diabetic gastroparesis.
Eligibility criteria
Qualifiers
Diagnosed with gastroparesis
Demonstrated delayed gastric emptying
Presence of moderate to severe nausea
Body Mass Index (BMI) of ≥18 and ≤40 kg/m2
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Tradipitant
Treatment groups
100 Participants
are divided into 1 treatment groupLocations
3Belgium
Vanda Investigational Site3000, Leuven Belgium
Vanda Investigational Site4000, Liège Belgium
Germany
Vanda Investigational Site04103, Leipzig Germany
Sponsors and collaborators
Vanda Pharmaceuticals
Lead sponsor
Source ClinicalTrials.gov