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dc.contributor.authorChapman, MJ
dc.contributor.authorJones, KL
dc.contributor.authorAlmansa, C
dc.contributor.authorBarnes, CN
dc.contributor.authorNguyen, D
dc.contributor.authorDeane, AM
dc.date.accessioned2020-11-27T00:02:00Z
dc.date.available2020-11-27T00:02:00Z
dc.date.issued2020-01-28
dc.identifier.citationChapman, M. J., Jones, K. L., Almansa, C., Barnes, C. N., Nguyen, D. & Deane, A. M. (2020). Blinded, Double-Dummy, Parallel-Group, Phase 2a Randomized Clinical Trial to Evaluate the Efficacy and Safety of a Highly Selective 5-Hydroxytryptamine Type 4 Receptor Agonist in Critically Ill Patients With Enteral Feeding Intolerance. JOURNAL OF PARENTERAL AND ENTERAL NUTRITION, 45 (1), pp.115-124. https://doi.org/10.1002/jpen.1732.
dc.identifier.issn0148-6071
dc.identifier.urihttp://hdl.handle.net/11343/252322
dc.description.abstractBACKGROUND: Delayed gastric emptying is the leading cause of enteral feeding intolerance (EFI) in critical illness. This phase 2a study compared TAK-954, a selective agonist of 5-hydroxytryptamine type 4 receptors, with metoclopramide in critically ill patients with EFI (NCT01953081). METHODS: A blinded, double-dummy trial was conducted in mechanically ventilated patients with EFI (>200 mL gastric residual volume within 24 hours before randomization). Patients were randomized to receive either 0.5 mg intravenous TAK-954 over 1 hour then 0.9% saline injection 4 times/d (sham metoclopramide) or the active comparator 10 mg intravenous metoclopramide 4 times/d and a 1-hour 0.9% saline infusion. After initial dosing, participants received a radiolabeled meal of liquid nutrient (Ensure; 106 kcal), and gastric emptying was measured (scintigraphy). Adverse events (AEs) were recorded from the time of consent through to day 5; serious AEs were collected to day 30. RESULTS: Thirteen patients (TAK-954, n = 7; metoclopramide, n = 6) participated. Five patients in the TAK-954 group and 4 in the metoclopramide group experienced AEs (2 and 3, respectively, were serious). All AEs except 1 (diarrhea in the metoclopramide group) were considered unrelated to study drug. Following treatment, a greater proportion of patients receiving TAK-954 had normal gastric retention (<13% retention at 180 minutes) than those receiving metoclopramide (6/7 vs 3/6 patients, respectively). CONCLUSION: A single dose of 0.5 mg intravenous TAK-954 appears to have at least similar efficacy in accelerating gastric emptying to multiple doses of 10 mg metoclopramide and was not associated with increased AEs.
dc.languageEnglish
dc.publisherWILEY
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0
dc.titleBlinded, Double-Dummy, Parallel-Group, Phase 2a Randomized Clinical Trial to Evaluate the Efficacy and Safety of a Highly Selective 5-Hydroxytryptamine Type 4 Receptor Agonist in Critically Ill Patients With Enteral Feeding Intolerance
dc.typeJournal Article
dc.identifier.doi10.1002/jpen.1732
melbourne.affiliation.departmentMedicine (RMH)
melbourne.affiliation.facultyMedicine, Dentistry & Health Sciences
melbourne.source.titleJournal of Parenteral and Enteral Nutrition
melbourne.source.volume45
melbourne.source.issue1
melbourne.source.pages115-124
dc.rights.licenseCC BY-NC-ND
melbourne.elementsid1434868
melbourne.contributor.authorDeane, Adam
dc.identifier.eissn1941-2444
melbourne.accessrightsOpen Access


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