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Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial
Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin: A Multicenter, Randomized, Double-Masked, Placebo-Controlled Trial
Study ID: IND - DK-GpCRC-4APRON; Secondary ID: U01DK073983; Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.
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. Screening for eligibility and collection of baseline data will span up to 4 weeks
after obtaining informed consent and registration. Eligible patients will consist of
patients with symptoms of gastroparesis and will be randomized to either aprepitant (125 mg
per day) or placebo for 4 weeks.
The symptoms will be measured with the Gastroparesis Cardinal Symptom Index Daily Diary
(GCSIDD)for one week at baseline and for four weeks after randomization. In addition, the
nausea symptom will be measured daily on a 0 to 100 mm visual analog scale (VAS)14 for one
week at baseline and daily for four weeks after randomization. There will be a 2 week
washout period at the end of the treatment to ensure patient safety following the end of
Age: 18 Years - N/A
- 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
- Another active disorder which could explain symptoms in the opinion of the
- 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
- Primary Outcome Measure
The primary outcome measure is a binary (0,1) variable indicating improvement in nausea or not in the mean of available VAS scores over the 28 day treatment period compared to the mean of VAS scores during the 7 day baseline period. The criteria for improvement are either a 25 mm or more reduction in mean VAS or attaining a mean VAS during the treatment period of < 25 mm.
Time frame: 4 weeks
- Gastrointestinal symptoms
Subscores for the GCSI: nausea/vomiting, postprandial fullness, bloating
Subscores for the GCSI Daily Diary
Individual symptom scores for nausea, retching or vomiting
Global overall relief of symptom questionnaire
Clinical global patient impression
Time frame: 4 weeks
Satiety test: Volume of Ensure ® consumed during satiety testing
Electrogastrography: Percent time in EGG dysrhythmias (outside 2.5-3.75 cycles per minute)
Side effects to treatment requiring stopping medication
Time frame: 4 weeks
- Frank Hamilton, MD, MPH; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (Study Director)
- Aynur Unalp-Arida, MD, PhD;
- James Tonascia, PhD;
|California Pacific Medical Center
||San Francisco, California
|University of Louisville
|Johns Hopkins Bayview Medical Center
|University of Michigan Medical Center
||Ann Arbor, Michigan
|Wake Forest University Health Sciences
||Winston-Salem, North Carolina
|Temple University Hospital
|Texas Tech University Health Sciences Center
||El Paso, Texas
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) - (Lead Sponsor)
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