Gastroparesis | Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial
Gastroparesis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:AprepitantAprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Drug:PlaceboAprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
AprepitantAprepitant 125 mg per day
Aprepitant-placeboPlacebo aprepitant 125mg per day
Start Date: April 2013
Completed Date: September 2015
Phase: Phase 3
Primary Outcome: Primary Outcome Measure
Secondary Outcome: Gastrointestinal symptoms
Study sponsors, principal investigator, and references
Principal Investigator: Frank Hamilton, MD, MPH
Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)