Status:
COMPLETED
Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Gastroparesis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 w...
Detailed Description
APRON is a multicenter, randomized, double-masked, placebo controlled trial of 4 weeks of treatment with aprepitant or placebo for patients with symptoms of gastroparesis and related disorders. Screen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT01149369
Start Date
April 1 2013
End Date
September 1 2015
Last Update
May 8 2019
Active Locations (8)
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1
California Pacific Medical Center
San Francisco, California, United States, 94115
2
Stanford University
Stanford, California, United States, 94305-5187
3
University of Louisville
Louisville, Kentucky, United States, 40202
4
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224