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Randomized Controlled Trial
, 20 (1), 232

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

Randomized Controlled Trial

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 et al. Crit Care.


Background: The 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.

Methods: A 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.

Results: Following 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.

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

Trial registration: The study protocol was registered with the US NIH on 23 December 2009 (Identifier NCT01039805 ).

Keywords: Absorption; Camicinal; Critical illness; Enteral nutrition; Gastric emptying; Motilin agonist.


Fig. 1
Fig. 1
Consort diagram. Next of kin consent was provided for six patients who subsequently did not receive study drug because of the following: feeding tube found to be in the duodenum, found to be hepatitis C positive after consent given, consent given and subsequently withdrawn, patient withdrawn by investigator (not in best interest of patient to continue), liver function tests elevated meeting exclusion criteria, patient died after consent given but prior to receiving study treatment. EN enteral nutrition, GRV gastric residual volumes
Fig. 2
Fig. 2
3-OMG (mean ± SEM) plasma concentrations vs. time in the placebo and 50 mg dose groups. 3-OMG 3-O-methyl glucose

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