Considerations for the OIC Clinical Trial Patient Population and Study Design

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Expert Insight into the Effectiveness and Economic Burden of Treatments for Opioid-Induced Constipation – Episode 6

William F. Peacock, MD

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

William F. Peacock, MD: We examined the patient population receiving single-dose opioid-induced constipation therapy, and we examined the cancer patient population, and we retrospectively assessed the health care economic implications. The only piece we are missing is a prospective randomized controlled trial in the emergency department setting. We have studies in the environment of services other than emergencies. We haven’t had a strong randomized controlled trial, which is something I’m pushing for because that would close the door on that. We have what appears to be a fairly effective option in the treatment of opioid-induced constipation, but ultimately we need a randomized controlled trial.

What you would like to see with a quality randomized controlled trial is effectiveness and then rates of admission versus intervention versus no. You want to make sure patients have a lasting benefit. How strong was this remedy? Are discharged patients kept on an outpatient basis? Because if I send someone home and they come back in 3 days, then I haven’t won. It’s just a booth. We want to make sure we fix their problem when they leave. This is difficult information to extract from a retrospective trial. It is in the interest of continuing the investigations.

Transcript edited for clarity

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