Evidence map›Paper›PMID 27476581›Full record

Trial reportCritical care (London, England)2016

The effect of camicinal (GSK962040), a motilin agonist, on gastric emptying and glucose absorption in feed-intolerant critically ill patients: a randomized, blinded, placebo-controlled, clinical trial.

Marianne J Chapman, Adam M Deane, Stephanie L O'Connor, Nam Q Nguyen, Robert J L Fraser, Duncan B Richards, Kimberley E Hacquoil, Lakshmi S Vasist Johnson, Matthew E Barton, George E Dukes

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Critical care (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01039805 (A Double-blind, Randomized, Placebo Controlled Phase II Study to Evaluate the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Single Doses of the Oral Motilin Receptor Agonist GSK962040, in Critically Ill Male and Female Patients With Enteral Feed Intolerance), which is not on this map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 pooled it
5.2field-weighted citation impact, top 4% of its field
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.

NCT01039805 phase2completednot on this map

A Double-blind, Randomized, Placebo Controlled Phase II Study to Evaluate the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Single Doses of the Oral Motilin Receptor Agonist GSK962040, in Critically Ill Male and Female Patients With Enteral Feed Intolerance

TypeinterventionalSponsorGlaxoSmithKlineRan2009 to 2011Enrolled34ConditionsGastroparesisArmsGSK962040 (50 mg), Placebo, GSK962040 (75 mg)
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 3 syntheses or guidelines pooled it, 43 citations in OpenAlex.

  1. Pooled it
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  3. Pooled it
  4. Article
  5. Review
  6. Reconsideration of the Gastroparetic Syndrome.Current gastroenterology reports · 2023
    Review
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  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. Article
  15. Starving for a Cure.Indian journal of endocrinology and metabolism
    Article
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

10 authors at 6 institutions in 3 countries.

Marianne J ChapmanDepartment of Critical Care Services, Royal Adelaide Hospital, North Terrace, Adelaide, Australia. marianne.chapman@health.sa.gov.au.
Adam M DeaneDepartment of Critical Care Services, Royal Adelaide Hospital, North Terrace, Adelaide, Australia.
Stephanie L O'ConnorDepartment of Critical Care Services, Royal Adelaide Hospital, North Terrace, Adelaide, Australia.
Nam Q NguyenDepartment of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, Australia.
Robert J L FraserDepartment of Gastroenterology and Hepatology, Flinders Medical Centre, Adelaide, Australia.
Duncan B RichardsGlaxoSmithKline, Stevenage, UK.
Kimberley E HacquoilGlaxoSmithKline, Stevenage, UK.
Lakshmi S Vasist JohnsonGlaxoSmithKline, Research Triangle Park, Durham, USA.
Matthew E BartonGlaxoSmithKline, Research Triangle Park, Durham, USA.
George E DukesGlaxoSmithKline, Research Triangle Park, Durham, USA.
Royal Adelaide Hospital · AUGlaxoSmithKline (United States) · USAge UK · GBFlinders Medical Centre · AUGlaxoSmithKline (United Kingdom) · GBResearch Triangle Park Foundation · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe promotility agents currently available to treat gastroparesis and feed intolerance in the critically ill are limited by adverse effects. The aim of this study was to assess the pharmacodynamic effects and pharmacokinetics of single doses of the novel gastric promotility agent motilin agonist camicinal (GSK962040) in critically ill feed-intolerant patients.

methodsA prospective, randomized, double-blind, parallel-group, placebo-controlled, study was performed in mechanically ventilated feed-intolerant patients [median age 55 (19-84), 73 % male, APACHE II score 18 (5-37) with a gastric residual volume ≥200 mL]. Gastric emptying and glucose absorption were measured both pre- and post-treatment after intragastric administration of 50 mg (n = 15) camicinal and placebo (n = 8) using the (13)C-octanoic acid breath test (BTt1/2), acetaminophen concentrations, and 3-O-methyl glucose concentrations respectively.

resultsFollowing 50 mg enteral camicinal, there was a trend to accelerated gastric emptying [adjusted geometric means: pre-treatment BTt1/2 117 minutes vs. post- treatment 76 minutes; 95 % confidence intervals (CI; 0.39, 1.08) and increased glucose absorption (AUC240min pre-treatment: 28.63 mmol.min/L vs. post-treatment: 71.63 mmol.min/L; 95 % CI (1.68, 3.72)]. When two patients who did not have detectable plasma concentrations of camicinal were excluded from analysis, camicinal accelerated gastric emptying (adjusted geometric means: pre-treatment BTt1/2 121 minutes vs. post-treatment 65 minutes 95 % CI (0.32, 0.91) and increased glucose absorption (AUC240min pre-treatment: 33.04 mmol.min/L vs. post-treatment: 74.59 mmol.min/L; 95 % CI (1.478, 3.449). In those patients receiving placebo gastric emptying was similar pre- and post-treatment.

conclusionsWhen absorbed, a single enteral dose of camicinal (50 mg) accelerates gastric emptying and increases glucose absorption in feed-intolerant critically ill patients.

trial registrationThe study protocol was registered with the US NIH clinicaltrials.gov on 23 December 2009 (Identifier NCT01039805 ).

Indexed as

AdultAgedAged, 80 and overCritical IllnessDouble-Blind MethodEnteral NutritionFeeding and Eating DisordersFemaleGastric AbsorptionGastric EmptyingGastrointestinal MotilityGlucoseHumansIntensive Care UnitsMaleMiddle AgedGlucoseN-(3-fluorophenyl)-1-((4-(((3S)-3-methyl-1-piperazinyl)methyl)phenyl)acetyl)-4-piperidinaminePiperazinesPiperidinesPlacebosAbsorptionCamicinalCritical illnessEnteral nutritionGastric emptyingMotilin agonist

Identifiers

PMID27476581
PMCPMC4967996
OpenAlexW2478708270

What OpenQuestion holds

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LicenceCC BY
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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.