NCT04785768

IV PCA With or Without Continuous Dose vs Oral Opioid to Maintain Analgesia for Severe Cancer Pain After Successful Titration

Intravenous (IV) Patient Controlled Analgesia (PCA) With or Without Continuous Dose vs Oral Opioid to Maintain Analgesia for Severe Cancer Pain After Successful Hydromorphone Titration: a Multi-center, Phase Ⅲ ，Randomized Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,372 (actual)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Based on the previous HMORCT09-2, the results show that IV PCA for analgesia maintenance improvements control of severe cancer pain after successful titration. Therefore, a study is planned to further explore the difference of efficacy and safety between PCA with continuous + bolus dose versus bolus-only.

Conditions

• Cancer Pain

Interventions

Type	Name	Description
DRUG	Hydromorphone Hydrochloride Injection	Intravenous PCA with hydromorphone after successful titration of 24 hours.the PCA setting: 1) continuous dose (dose/hours) = the total dosage of hydromorphone in the previous 24 hours/24; 2) bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours; 3) lockout time = 10 minutes; 4）Evaluate every 24 hours and PCA parameters were adjusted according to the dose of the previous day.
DRUG	Hydromorphone Hydrochloride Injection	Intravenous PCA with hydromorphone after successful titration of 24 hours.the PCA setting: 1) continuous dose = 0; 2) bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours: 3) lockout time = 10 minutes; 4)Evaluate every 24 hours and PCA parameters were adjusted according to the dose of the previous day.
DRUG	Morphine Sulfate Sustained-release Tablets	Swift to sustained-release morphine orally as background dose with immediate release morphine orally for breakthrough pain after successful titration of 24 hours. Administration of morphine orally 1) Sustained-release morphine orally (dose/12 hours) = the total equianalgesic of the previous 24 hours/2×75% for day 1; 2）the total equianalgesic of the previous 24 hours/2 for day 2 ; 3）Evaluate every 24 hours and the dose for the next day is adjusted according to the dose of the previous day；4) Immediate release morphine orally = 10-20% of the total equianalgesic of the previous 24 hours;

Timeline

• Start date: 2021-07-01
• Primary completion: 2024-05-01
• Completion: 2024-07-01
• First posted: 2021-03-08
• Last updated: 2025-05-22

Locations

1 site across 1 country: China