Efficacy and safety study of low-dose oxycodone versus tramadol in patients with moderate cancer pain from different ethnic groups: a multicenter randomized controlled open-label trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500107474

Enrollment

Unknown

Registered

2025-08-12

Start date

2025-09-30

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer pain

Interventions

Control group:Oral administration of tramadol sustained-release tablets

Experimental group:Oral administration of hydrocodone sustained-release tablets

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Cancer patients aged 18-65 years; 2. NRS score of 4-6 points for opioid intolerant patients; 3. KPS score of 60 points or above; 4. No cognitive impairment or mental illness; 5. Expected survival of at least 3 months.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to opioid use; 2. Patients with chronic renal failure, severe liver or respiratory failure, malabsorption syndrome, uncontrollable diarrhea and nausea and vomiting caused by cancer treatment, intestinal obstruction, and radiation therapy; 3. Patients with investigational drugs currently in use; 4. Patients who cannot take oral medication; 5. Suffering from non-tumor-related pain or unexplained pain, such as osteoarthritis pain, low back pain, etc.; cancer pain emergency; 6. Patients with complex cancer pain or refractory cancer pain; 7. Patients who are suffering from infection, abscess, or fever; Patients with a history of drug or alcohol abuse; 8. Patients who are not suitable to participate in this study for any reason other than the inclusion criteria and exclusion criteria according to the judgment of the investigator.

Design outcomes

Primary

Measure	Time frame
Numeric Rating Scale Score;	—

Secondary

Measure	Time frame
Maintenance of daily rescue and analgesic medication for burst pain during the treatment period (frequency of burst pain and rescue dose);Time for stable pain control;KPS Quality of Life Score;ESAS Symptom Score;Daily rescue analgesic medication during titration/dose adjustment period (frequency of pain outbreaks and rescue dose);Drug conversion ratio and dosage/drug maintenance rate;QEI (OMD-OSD)/OSD/days *100);Usage of auxiliary drugs;Satisfaction assessment;Safety and tolerability, proportion of patients with adverse reactions or other adverse events, treatment interruption due to ineffective or adverse events;The respective proportions of patients with pain relief >= 30% and pain relief >= 50% within 1, 2, and 3 days;	—

Measure

Time frame

Maintenance of daily rescue and analgesic medication for burst pain during the treatment period (frequency of burst pain and rescue dose);Time for stable pain control;KPS Quality of Life Score;ESAS Symptom Score;Daily rescue analgesic medication during titration/dose adjustment period (frequency of pain outbreaks and rescue dose);Drug conversion ratio and dosage/drug maintenance rate;QEI (OMD-OSD)/OSD/days *100);Usage of auxiliary drugs;Satisfaction assessment;Safety and tolerability, proportion of patients with adverse reactions or other adverse events, treatment interruption due to ineffective or adverse events;The respective proportions of patients with pain relief >= 30% and pain relief >= 50% within 1, 2, and 3 days;

—

Countries

China

Contacts

Public ContactZhang Aimin

Sichuan Cancer Hospital

zhangaimin@scszlyy.org.cn+86 13558115400

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026