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