MetAddon: Methadone as co-analgesic for patients with metastatic bone pain: a double-blind randomized controlled trial

Condition studied

Cancer, bone metastasis, pain

Investigational medicinal product(s)

Eligibility

Primary endpoint

Difference in proportion of patients with ≥ 30% reduction in mean pain between both groups based on average scores of day 5, 6 and 7 using an 11-point scale.

Endpoint detail

Mean and worst pain intensity after each week using an 11-point scale., Time in days between start study medication andreaching ≥ 30% reduction in mean pain score., Mean pain intesity using 11-point scale on day 21 compared to mean pain inensity at baseline., Global perceibed effect after three weeks., Frequency use of rescue medication throughout the study, Self-reported side effects on day 1, 7, 8, 14 and 21 using medcation and pain diary on an 7-point scale and complications via (S)AE reports., Health-related quality of life at baseline and after 7, 14 and 21 days using EQ-5D-5L and FACT-BP questionnaires., Health-care costs and cost-effectiveness at three weeks., Opioid increased ratio: difference in daily opioid dose on day 21 compared to baseline.