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

Completed · Phase 2 · Has a placebo group

Conditions studied: Gastroparesis

In brief

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.

Key facts

Study ID

NCT01149369

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

126

Starts

2013-04-01

Expected to finish

2015-09-01

Last updated by the study team

2019-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• California Pacific Medical Center — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• University of Louisville — Louisville, Kentucky, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Texas Tech University Health Sciences Center — El Paso, Texas, United States

Full record on ClinicalTrials.gov

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