Objective - Efficacy and safety of a novel multiple-unit hydromorphone once daily (HOD) was compared to an established hydromorphone twice daily (HTD) regimen in patients with moderate-to-severe chronic pain.
Design and methods - The results from a randomized, double-blind, multicenter, cross-over trial in patients (n = 37) with chronic malignant or non-malignant pain are reported. Primary efficacy parameter was current pain on 0-100 mm VAS assessed 4-times daily and prior to intake of rescue medication (immediate-release hydromorphone) throughout the last 5 days with each treatment (after an 8-day build-up period to avoid carry-over effects). Total daily dose of hydromorphone (TDD: 8 to 32 mg/day) was kept stable during the double-blind treatment phase.
