Gastroparesis Clinical Trial
Official title:
Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin: A Multicenter, Randomized, Double-Masked, Placebo-Controlled Trial
The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether 4 weeks of treatment with aprepitant will improve nausea as compared with placebo in patients with symptoms of chronic nausea and vomiting of presumed gastric origin.
APRON is a multicenter, randomized, double-masked, placebo controlled trial of 4 weeks of
treatment with aprepitant or placebo for patients with symptoms of gastroparesis and related
disorders. Screening for eligibility and collection of baseline data will span up to 4 weeks
after obtaining informed consent and registration. Eligible patients will consist of patients
with symptoms of gastroparesis and will be randomized to either aprepitant (125 mg per day)
or placebo for 4 weeks.
The symptoms will be measured with the Gastroparesis Cardinal Symptom Index Daily Diary
(GCSIDD) for one week at baseline and for four weeks after randomization. In addition, the
nausea symptom will be measured daily on a 0 to 100 mm visual analog scale (VAS) for one week
at baseline and daily for four weeks after randomization. There will be a 2 week washout
period at the end of the treatment to ensure patient safety following the end of treatment.
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