Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis
Recruiting
Phase 3
Interventional Study
Idiopathic Gastroparesis
Diabetic Gastroparesis
Gastroparesis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- Vanda Pharmaceuticals · Industry
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About This Trial
This is a multicenter, open label, 3-month safety study with tradipitant in patients with idiopathic and diabetic gastroparesis.
Trial Locations
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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…
Contacts