OIC Clinical Trial Patient Population and Study Design Considerations

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