Overview

Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial

Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Treatments:
Aprepitant
Fosaprepitant
Criteria
Inclusion Criteria:

- Age 18 years or older at registration

- Gastric emptying scintigraphy within 2 years of registration

- Normal upper endoscopy or upper GI series within 2 years of registration

- Symptoms of chronic nausea or vomiting compatible with gastroparesis or other
functional gastric disorder for at least 6 months (does not have to be contiguous)
prior to registration with Gastroparesis Cardinal Symptom Index (GCSI) score of
greater than or equal to 21

- Significant nausea defined with a visual analog scale (VAS) score of greater than or
equal to 25 mm on a 0 to 100 mm scale

Exclusion Criteria:

- Another active disorder which could explain symptoms in the opinion of the
investigator

- Use of narcotics more than 3 days per week

- Significant hepatic injury as defined by significant alanine aminotransferase (ALT)
and aspartate aminotransferase (AST) elevations of greater than 2x the upper limit of
normal (ULN) or a Child-Pugh score of 10 or greater

- Contraindications to aprepitant such as hypersensitivity or allergy

- Concurrent use of warfarin, pimozide, terfenadine, astemizole, or cisapride

- Pregnancy or nursing

- Any other condition, which in the opinion of the investigator would impede compliance
or hinder the completion of the study

- Failure to give informed consent