drugset / Trial / NCT03564548

Inhaled Cannabinoids Versus Immediate-release Oral Opioids for the Management of Breakthrough Cancer Pain

NCT03564548

RandomizedCrossoverTriple-blindTreatment

Summary

Breakthrough cancer pain (BTcP) is a rapid onset, high intensity and short duration pain episode, which takes place within stable background pain control. It significantly affects the quality of life of patients with cancer and their ability to function normally. Rapid onset opioids and immediate-release oral opioids (e.g. morphine sulfate, hydromorphone, and oxycodone) are the standard treatment for BTcP. Because of the limited availability, high cost, complicated titration and the high risks of overdosing with rapid-onset opioids, most often the preferred choice of treatment is immediate-release oral opioids. However, this approach might not always offer optimal speed for onset of action and duration to match the rapid nature of an episode of BTcP. In order to seek a potential alternative to immediate-release oral opioids, we are proposing to test the onset of action of PPP001 to rapidly alleviate breakthrough pain in patients with cancer. We will also examine the safety and the efficacy on pain intensity of PPP001 within this population.

Timeline

Start
2021-05-26
Primary completion
2022-03
Completion
2022-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hydromorphone Other / unclassified Oral
Comparator Morphine Other / unclassified Oral
Comparator Oxycodone Other / unclassified Oral
Subject PPP001 Traditional medicine (herbal / TCM) Inhaled

Indications