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
Marianne J Chapman, Karen L Jones, Cristina Almansa, Chris N Barnes, Deanna Nguyen, Adam M Deane
Journal of Parenteral and Enteral Nutrition | WILEY | Published : 2020
BACKGROUND: 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. ..View full abstract
The study was supported by an unrestricted grant from Theravance Biopharma to the Royal Adelaide Hospital. K.L.J. received funding from Theravance Biopharma to perform the gastric emptying analyses. A.M.D. received a travel grant from Takeda to present these data at Digestive Diseases Week 2018. M.J.C. did not receive payment, stock, or travel grants from Theravance Biopharma and has no duality of interest. A.M.D. wrote the initial draft of the manuscript, which was edited by all authors. Takeda provided manuscript support via a third-party medical writing service, Oxford PharmaGenesis Ltd, who updated the manuscript on behalf of the authors, collating the supplementary materials, developing figures, editing and quality-checking the content, and supporting submission.