title: Prospective, randomized, controlled, proof-of-concept study of the Ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients.
abstract: BACKGROUND
  Postoperative ileus is a significant clinical challenge lacking effective management strategies. Ghrelin-receptor stimulation has promotility effects in the upper and lower gastrointestinal tract.
  
  
  OBJECTIVE
  This proof-of-concept, phase 2, randomized study evaluated the safety and efficacy of the ghrelin-receptor agonist ipamorelin in the treatment of postoperative ileus following abdominal surgery (ClinicalTrials.gov NCT00672074).
  
  
  METHODS
  The design was a multicenter, double-blind, placebo-controlled, clinical trial.
  
  
  METHODS
  The settings include hospital inpatients.
  
  
  METHODS
  The patients were adults undergoing small and large bowel resection by open or laparoscopic surgery.
  
  
  METHODS
  The intervention was intravenous infusions of 0.03-mg/kg ipamorelin vs placebo twice daily, on postoperative day 1 to 7 or hospital discharge.
  
  
  METHODS
  Safety was assessed by monitoring adverse events and laboratory tests. The key efficacy endpoint was time from first dose of study drug to tolerance of a standardized solid meal.
  
  
  RESULTS
  One hundred seventeen patients were enrolled, of whom 114 patients composed the safety and modified intent-to-treat populations. Demographic and disease characteristics were balanced between groups. Overall incidence of any treatment-emergent adverse events was 87.5 % in the ipamorelin group and 94.8 % in placebo group. Median time to first tolerated meal was 25.3 and 32.6 h in the ipamorelin and placebo groups, respectively (p = 0.15).
  
  
  CONCLUSIONS
  This proof of concept study was small and enrolled patients with a broad range of underlying conditions.
  
  
  CONCLUSIONS
  Ipamorelin 0.03-mg/kg twice daily for up to 7 days was well tolerated. There were no significant differences between ipamorelin and placebo in the key and secondary efficacy analyses.
authors.affiliation: Department of Colon and Rectal Surgery Ochsner Clinic Foundation, New Orleans, Louisiana, The University of Queensland School of Medicine Ochsner Clinical School, Brisbane, Australia, 1514 Jefferson Highway, 70121, New Orleans, Louisiana, USA, dbeckmd@aol.com.
authors.forename: David E
authors.initials: DE
authors.lastname: Beck
authors.forename: W Brian
authors.initials: WB
authors.lastname: Sweeney
authors.forename: Martin D
authors.initials: MD
authors.lastname: McCarter
mesh_terms: D004311:Double-Blind Method; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D045823:Ileus / Q000188:drug therapy* / Q000209:etiology; D007422:Intestines / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009842:Oligopeptides / Q000009:adverse effects / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000188:drug therapy*; D011446:Prospective Studies; D054440:Receptors, Ghrelin / Q000819:agonists*; D014839:Vomiting / Q000139:chemically induced
chemical_list: D005765:Gastrointestinal Agents; D009842:Oligopeptides; D054440:Receptors, Ghrelin; C114611:ipamorelin