View Clinical Trial (Medical Research Study)

Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial - NCT01149369-94305(Clinical Trial 680366)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  Stanford
State:  
CA
Zip Code: 94305
Conditions: Gastroparesis
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.
Study summary:
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 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 2xULN 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
Study is available at: Stanford University
Stanford, CA 94305
United States

Primary Contact:
James Tonascia, PhD
Email: jtonasci@jhsph.edu
Phone: 410-955-3704
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.