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Human evidence record ยท Ipamorelin

Ipamorelin for postoperative ileus after bowel resection

Median time was 25.3 hours with ipamorelin versus 32.6 hours placebo; difference was not statistically significant (P=0.15). Key and secondary efficacy analyses were not significant.

Quick read
Human evidence record

What this study tells us

Participants were assigned to comparison groups by chance, usually with placebo and/or blinding to reduce bias. This is a strong design for testing cause and effect, but the population, duration and endpoints still limit what can be concluded.

Who was studied?

Adults undergoing small or large bowel resection

How many?

n=117 enrolled; 114 safety/mITT

What happened?

Median time was 25.3 hours with ipamorelin versus 32.6 hours placebo; difference was not statistically significant (P=0.15). Key and secondary efficacy analyses were not significant.

What stops us overclaiming?

Post-surgical inpatient population and IV route; cannot be extrapolated to subcutaneous wellness/bodybuilding use.

Need help with terms such as randomized, placebo, endpoint or sample size? Open the glossary โ†’

Key result

Median time was 25.3 hours with ipamorelin versus 32.6 hours placebo; difference was not statistically significant (P=0.15). Key and secondary efficacy analyses were not significant.

Study details

Study designMulticenter, randomized, double-blind, placebo-controlled proof-of-concept trial
PhasePhase II
PopulationAdults undergoing small or large bowel resection
Sample size117 enrolled; 114 safety/mITT
RouteIntravenous
Regimen / exposure0.03 mg/kg twice daily from postoperative day 1 through day 7 or discharge
DurationUp to 7 days
ComparatorPlacebo
Primary endpoint / questionTime from first dose to tolerance of a standardized solid meal
Safety resultAny treatment-emergent adverse event occurred in 87.5% versus 94.8% placebo; FDA later cited serious adverse events including death in the IV clinical programme.
Key limitationsPost-surgical inpatient population and IV route; cannot be extrapolated to subcutaneous wellness/bodybuilding use.
Registry / identifierPMID 25331030 / NCT00672074