Evidence map›Paper›PMID 29111115›Full record

Trial reportGastroenterology2018

Aprepitant Has Mixed Effects on Nausea and Reduces Other Symptoms in Patients With Gastroparesis and Related Disorders.

Pankaj J Pasricha, Katherine P Yates, Irene Sarosiek, Richard W McCallum, Thomas L Abell, Kenneth L Koch, Linda Anh B Nguyen, William J Snape, William L Hasler, John O Clarke and 11 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Gastroenterology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01149369 (Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin), which is not on this map. Cited by 40 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01149369 phase2completednot on this map

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

TypeinterventionalSponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Ran2013 to 2015Enrolled126ConditionsGastroparesisArmsAprepitant, Placebo
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Guideline
  2. Guideline
  3. Guideline
  4. Pooled it
  5. Guideline
  6. Review
  7. Progress in Gastroparesis Management: From Pharmacotherapy to Interventional Treatments.JGH open : an open access journal of gastroenterology and hepatology · 2026
    Review
  8. Article
  9. Pharmacologic treatments for gastroparesis.Pharmacological reviews · 2025
    Review
  10. Article
  11. Article
  12. Review
  13. Review
  14. Reconsideration of the Gastroparetic Syndrome.Current gastroenterology reports · 2023
    Review
  15. Article
  16. Article
  17. Gastroparesis: Myths, Misconceptions, and Management.Clinical and experimental gastroenterology · 2023
    Review
  18. Progress in Gastroparesis - A Narrative Review of the Work of the Gastroparesis Clinical Research Consortium.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2022
    Review
  19. Article
  20. Gastroparesis.Gastroenterology · 2022
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

Pankaj J PasrichaJohns Hopkins University School of Medicine, Baltimore, MD. Electronic address: ppasric1@jhmi.edu.
Katherine P YatesJohns Hopkins University Bloomberg School of Public Health, Baltimore, MD.
Irene SarosiekTexas Tech University, El Paso, TX.
Richard W McCallumTexas Tech University, El Paso, TX.
Thomas L AbellUniversity of Louisville, Louisville, KY.
Kenneth L KochWake Forest University, Winston-Salem, NC.
Linda Anh B NguyenStanford University, Palo Alto, CA.
William J SnapeCalifornia Pacific Medical Center, San Francisco, CA.
William L HaslerDivision of Gastroenterology, University of Michigan Health System, Ann Arbor, MI.
John O ClarkeJohns Hopkins University School of Medicine, Baltimore, MD.
Sameer DhallaJohns Hopkins University School of Medicine, Baltimore, MD.
Ellen M SteinJohns Hopkins University School of Medicine, Baltimore, MD.
Linda A LeeJohns Hopkins University School of Medicine, Baltimore, MD.
Laura A MirielJohns Hopkins University Bloomberg School of Public Health, Baltimore, MD.
Mark L Van NattaJohns Hopkins University Bloomberg School of Public Health, Baltimore, MD.
Madhusudan GroverMayo Clinic College of Medicine, Rochester, MN.
Gianrico FarrugiaMayo Clinic College of Medicine, Rochester, MN.
James TonasciaJohns Hopkins University Bloomberg School of Public Health, Baltimore, MD.
Frank A HamiltonNational Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD.
Henry P ParkmanTemple University, Philadelphia, PA.
NIDDK Gastroparesis Clinical Research Consortium (GpCRC)

Funding

Michigan Institute for Clinical and Health Research (MCHR)UL1TR000433 · NCATS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI MASHOUR, GEORGE ALEXANDER · 2012 to 2016
$49.9M
Mayo Clinic Center for Translational Science ActivitiesUL1TR000135 · NCATS · MAYO CLINIC ROCHESTER · PI KHOSLA, SUNDEEP · 2012 to 2015
$41.2M
UT Southwestern Center for Translational Medicine (UL1/KL2/TL1)UL1TR001105 · NCATS · UT SOUTHWESTERN MEDICAL CENTER · PI TOTO, ROBERT DANIEL · 2013 to 2017
$24.5M
Gastroparesis Consortium Continuation-Data Coordinating CenterU01DK074008 · NIDDK · JOHNS HOPKINS UNIVERSITY · PI TONASCIA, JAMES A · 2006 to 2015
$17.4M
PGpR2 Year 4 Supplement for the Scientific Data Research Center (SDRC) of the GpCRC 4U24DK074008 · NIDDK · JOHNS HOPKINS UNIVERSITY · PI David M Shade · 2017 to 2026
$11.7M
Subtypes of GastroparesisU01DK073974 · NIDDK · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI Baharak Moshiree · 2006 to 2026
$7.4M
Temple University Gastroparesis Clinical CenterU01DK073975 · NIDDK · TEMPLE UNIV OF THE COMMONWEALTH · PI HENRY PAUL PARKMAN · 2006 to 2026
$7.4M
U of L Clinical Center to Investigate the Pathogenesis, Etiology, and Treatment of Gastroparesis through the NIDDK Gastroparesis ConsortiumU01DK074007 · NIDDK · UNIVERSITY OF MISSISSIPPI MED CTR · PI Thomas Lyman Abell · 2006 to 2026
$7.0M
Molecular Approaches to Pathogenesis/Therapy in GastropaU01DK073983 · NIDDK · UNIVERSITY OF TEXAS MED BR GALVESTON · PI PANKAJ J PASRICHA · 2006 to 2026
$6.8M
The GpCRC Pediatric Gastroparesis Registry 2 (PGpR2): Characterization and Clinical Course of Symptoms and Gastric Emptying in Pediatric, Adolescent, and Young Adult Participants with Symptoms of GastU01DK074035 · NIDDK · UNIVERSITY OF KANSAS MEDICAL CENTER · PI Irene Sarosiek · 2008 to 2026
$6.7M
Stanford Center for Clinical and Translational Education and Research (SCCTER)UL1UL1TR000093 · NCATS · STANFORD UNIVERSITY · PI GREENBERG, HARRY BERNARD · 2012 to 2013
$6.5M
Institute for Clinical and Translational ResearchUL1TR000424 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2012 to 2012
$6.0M
NCATS NIH HHS UL1 TR000093NCATS NIH HHS UL1 TR000135NCATS NIH HHS UL1 TR000424NCATS NIH HHS UL1 TR000433NCATS NIH HHS UL1 TR001105NIDDK NIH HHS K23 DK103911NIDDK NIH HHS U01 DK073974NIDDK NIH HHS U01 DK073975NIDDK NIH HHS U01 DK073983NIDDK NIH HHS U01 DK073985NIDDK NIH HHS U01 DK074007NIDDK NIH HHS U01 DK074008NIDDK NIH HHS U01 DK074035NIDDK NIH HHS U01 DK112193NIDDK NIH HHS U24 DK074008
6 · The paper itself

Abstract

BACKGROUND &

aimsThere are few effective treatments for nausea and other symptoms in patients with gastroparesis and related syndromes. We performed a randomized trial of the ability of the neurokinin-1 receptor antagonist aprepitant to reduce symptoms in patients with chronic nausea and vomiting caused by gastroparesis or gastroparesis-like syndrome.

methodsWe conducted a 4-week multicenter, double-masked trial of 126 patients with at least moderate symptoms of chronic nausea and vomiting of presumed gastric origin for a minimum of 6 months. Patients were randomly assigned to groups given oral aprepitant (125 mg/day, n = 63) or placebo (n = 63). The primary outcome from the intention-to-treat analysis was reduction in nausea, defined as a decrease of 25 mm or more, or absolute level below 25 mm, on a daily patient-reported 0-to-100 visual analog scale (VAS) of nausea severity. We calculated relative risks of nausea improvement using stratified Cochran-Mental-Haenszel analysis.

resultsAprepitant did not reduce symptoms of nausea, based on the primary outcome measure (46% reduction in the VAS score in the aprepitant group vs 40% reduction in the placebo group; relative risk, 1.2; 95% CI, 0.8-1.7) (P = .43). However, patients in the aprepitant group had significant changes in secondary outcomes such as reduction in symptom severity (measured by the 0-5 Gastroparesis Clinical Symptom Index) for nausea (1.8 vs 1.0; P = .005), vomiting (1.6 vs 0.5; P = .001), and overall symptoms (1.3 vs 0.7; P = .001). Adverse events, predominantly mild or moderate in severity grade, were more common in aprepitant (22 of 63 patients, 35% vs 11 of 63, 17% in the placebo group) (P = .04).

conclusionsIn a randomized trial of patients with chronic nausea and vomiting caused by gastroparesis or gastroparesis-like syndrome, aprepitant did not reduce the severity of nausea when reduction in VAS score was used as the primary outcome. However, aprepitant had varying effects on secondary outcomes of symptom improvement. These findings support the need to identify appropriate patient outcomes for trials of therapies for gastroparesis, including potential additional trials for aprepitant. ClinicalTrials.gov no: NCT01149369.

Indexed as

AdultAntiemeticsAprepitantChronic DiseaseDouble-Blind MethodFemaleGastroparesisHumansMaleMiddle AgedMorpholinesNauseaTreatment OutcomeVomitingAntiemeticsAprepitantMorpholinesAprepitant TreatmentChronic Nausea and VomitingGastroparesisRCT

Identifiers

PMID29111115
PMCPMC5742047

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.