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

Trial ID or NCT#

NCT01149369

Status

not recruiting iconNOT RECRUITING

Purpose

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.

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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
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Investigator(s)

Linda Nguyen
Linda Nguyen
Gastroenterologist, Motility specialist
Clinical Professor, Medicine - Gastroenterology & Hepatology

Contact us to find out if this trial is right for you.

Contact

Linda B Nguyen, MD
650-725-3362

View on ClinicalTrials.gov