Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

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

Stanford Investigator(s):

Intervention(s):

  • Drug: Aprepitant
  • Drug: Placebo

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Linda B Nguyen, MD
650-725-3362
Not Recruiting