Study wrapper · #202
Prospective, randomized, controlled, proof-of-concept study of the Ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients.
Editor's note
This is the strongest study in the batch by design: a multicentre, double-blind, placebo-controlled Phase 2 randomised trial (NCT00672074) of intravenous ipamorelin for postoperative ileus in 114 adults after bowel resection. It is a genuine efficacy trial, not a mention — and the result was negative. Median time to tolerating a solid meal was 25.3 hours on ipamorelin versus 32.6 hours on placebo, but the difference was not statistically significant (p=0.15), and no secondary efficacy endpoint separated from placebo either. On the safety side, treatment-emergent adverse events were common in both arms (87.5% ipamorelin vs 94.8% placebo), and the authors reported ipamorelin was well tolerated at this dose and duration. Weigh this carefully: a ghrelin-receptor agonist has a mechanistically plausible promotility rationale, and the numeric trend favoured ipamorelin, but this adequately blinded trial did not demonstrate benefit. It stands as a rare controlled human dataset for ipamorelin and a useful counterweight to mechanistic optimism from rodent ileus models.
Plain-language abstract
Postoperative ileus — a temporary shutdown of normal gut movement after abdominal surgery — has few good treatments. Because the ghrelin receptor helps drive gut motility, researchers tested ipamorelin, a drug that activates that receptor, in a well-designed clinical trial. This was a multicentre, randomised, double-blind, placebo-controlled Phase 2 study: neither patients nor doctors knew who got the drug. 117 adults having small or large bowel removal were enrolled (114 analysed), receiving intravenous ipamorelin (0.03 mg/kg) or placebo twice daily for up to 7 days. The main measure was how long until a patient could tolerate a normal solid meal. Patients on ipamorelin reached that point at a median of 25.3 hours versus 32.6 hours on placebo — a difference that was not statistically significant (p=0.15). No other efficacy measure showed a clear advantage. Side effects were common in both groups (87.5% with ipamorelin, 94.8% with placebo), and the drug was reported as well tolerated at this dose. The authors noted the study was small with a varied patient mix. Bottom line: this trial did not show that ipamorelin worked better than placebo for this use.