OIC Clinical Trial Patient Population and Study Design Considerations


An expert in emergency medicine shares his thoughts on the patient population inclusion criteria study designs when investigating treatment efficacy in patients with opioid-induced constipation.

William F. Peacock, MD: We’ve looked at the population of patients with single-dose opioid-induced constipation therapy, and we’ve looked at the population of patients with cancers, and we’ve evaluated the health care economic implications retrospectively. The 1 piece we’re missing is a randomized prospective-controlled trial in the emergency department environment. We have studies in the non–emergency department environment. We haven’t had a solid randomized controlled trial, which is 1 thing I’m pushing for because it would close the door on this. We have what looks like a pretty effective option in the treatment of opioid-induced constipation, but ultimately we need a randomized control trial.

What you’d like to see with a quality randomized control trial is efficacy and then admission rates vs intervention vs not. You’d want to make sure the patients had a lasting benefit. How robust was this cure? Are patients who are discharged maintained as outpatients? Because if I send somebody home and they come back in 3 days, then I haven’t won. It’s just a stall. We want to make sure we’re curing their problem when they leave. This is information that’s hard to pull out of a retrospective trial. That’s the point of continuing the investigations.

Transcript Edited for Clarity

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