METHADONE HYDROCHLORIDE for Bone metastases | Cancer-related bone pain

Inclusion criteria

• {"criterion_text":"- Patients have metastatic bone pain reflected by a mean pain intesity score of ≥5 on an 11-point scale.\n- Patients use strong opioids at a stable dose for at least seven days with a minimal daily dose of 60 mg MME (morphine milligram equivalence) (oxycodone SR 40 mg, fentanyl TD 25 mcg/hr, hydromorphine SR 12 mg).\n- Patients are 18 years or older.\n- Female patients of childbearing potential use contraceptives to prevent pregnancy during the study period."}

Exclusion criteria

• {"criterion_text":"- Patients who have prolonged QT syndrome.\n- Patients who are scheduled for radiotherapy on bone lesions during the study period.\n- Patients who have an indication for surgery to prevent pathological fractures.\n- Patients who use irreversible monoamine oxidase (MAO) inhibitors within the last 14 days or during the study period.\n- Patients who use enzalutamide in the last four weeks or during the study period.\n- Patients who have myasthenia gravis.\n- Patients who are pregnant.\n- Patients who have a QTc-time > 500 ms (ECG max three months old).\n- Patients with an eGFR < 30 mL/min (max. six weeks old).\n- Patients who use buprenorphine, morphine SR or methadone.\n- Patients who are not able to take oral medication.\n- Patients who experience pain caused by a pathologic fracture or (suspected) nerve root compression.\n- Patients who experience pain most likely not related to bone metastasis.\n- Patients who have had surgery within seven days before the start of the study.\n- Patients who received radiotherapy within the last six weeks on bone lesions."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Proportion of patients achieving ≥30% reduction in mean pain based on the average scores of day 5, 6 and 7 using an 11-point pain scale."}

Secondary endpoints

• {"endpoint_text":"- Mean and worst pain intensity after each week using an 11-point scale.","definition_or_measurement_approach":"Mean and worst pain intensity measured weekly using an 11-point pain scale."}
• {"endpoint_text":"- Time in days between start study medication andreaching ≥ 30% reduction in mean pain score.","definition_or_measurement_approach":"Time (in days) from start of study medication to achieving ≥30% reduction in mean pain score."}
• {"endpoint_text":"- Mean pain intesity using 11-point scale on day 21 compared to mean pain inensity at baseline.","definition_or_measurement_approach":"Comparison of mean pain intensity on day 21 vs baseline using an 11-point scale."}
• {"endpoint_text":"- Global perceibed effect after three weeks.","definition_or_measurement_approach":"Global perceived effect assessed after three weeks (measure as described in protocol)."}
• {"endpoint_text":"- Frequency use of rescue medication throughout the study","definition_or_measurement_approach":"Frequency of use of rescue (breakthrough) medication recorded throughout the study."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Self-reported side effects recorded on days 1, 7, 8, 14 and 21 using a medication and pain diary on a 7-point scale; complications captured via (S)AE reports."}
• {"endpoint_text":"- Health-related quality of life at baseline and after 7, 14 and 21 days using EQ-5D-5L and FACT-BP questionnaires.","definition_or_measurement_approach":"HRQoL measured at baseline and days 7, 14, 21 using EQ-5D-5L and FACT-BP questionnaires."}
• {"endpoint_text":"- Health-care costs and cost-effectiveness at three weeks.","definition_or_measurement_approach":"Health-care costs and cost-effectiveness evaluated at three weeks (methods per protocol)."}
• {"endpoint_text":"- Opioid increased ratio: difference in daily opioid dose on day 21 compared to baseline.","definition_or_measurement_approach":"Difference in daily opioid dose on day 21 compared to baseline (opioid increase ratio)."}

Netherlands

Earliest CTIS Part Ii Submission Date

09-10-2025

Latest Decision Or Authorization Date

15-04-2026

Processing Time Days

188

Number Of Sites

8

Number Of Participants

166

Primary sponsor

Full Name

Universiteit Maastricht

Organisation Type

Educational Institution

Country Of Registered Address

Netherlands