moderate-to-severe cancer pain
Conditions
Interventions
Experimental group:Take Rui Anning (Oxycodone Hydrochloride Extended-Release Tablets)
Control group:Take OxyContin (Oxycodone Hydrochloride Extended-Release Tablets)
Sponsors
Beijing Friendship Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years, no gender restriction; 2. Subjects have a documented history of moderate-to-severe chronic cancer pain requiring continuous use of opioid analgesics (including pain that is well-controlled or poorly controlled) and are potentially able to benefit from WHO Step III opioid analgesic therapy during the study treatment period. Subjects are willing to discontinue their current opioid analgesic therapy; 3. Subjects who have experienced cancer pain within the past 24 hours with a Numerical Rating Scale (NRS) score >=4; 4. Subjects sign the informed consent form to demonstrate their willingness and ability (e.g., mental and physical condition) to participate in all aspects of the study, including taking oral medication, completing subjective assessments, attending scheduled study center visits, completing telephone follow-ups, and complying with protocol requirements; 5. Subjects who are using non-opioid analgesics and all other concomitant medications (including antidepressants) prior to the study may continue taking them under the supervision of the investigator, provided that the doses are stable and necessary to maintain the subject's good condition, and are expected to remain unchanged throughout the entire treatment period; 6. Patients requiring chemotherapy, long-term hormone therapy, targeted therapy, or bisphosphonate therapy have received stable anti-tumor treatment prior to randomization; 7. Patients who have not received radiotherapy within 7 days prior to randomization and the start of the study; 8. No history of allergy to narcotic drugs; 9. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score =3 months.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with non-cancer pain or pain of unknown origin; 2. History of allergy to oxycodone, morphine, study-related medications, or any related components; 3. Subjects with any contraindications to opioid use, severe respiratory depression, hypoxia and/or hypercapnia, severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, paralytic ileus, etc.; 4. Subjects with clinically significant evidence of gastrointestinal disease (e.g., paralytic ileus, peritoneal carcinomatosis), gastrointestinal structural abnormalities (e.g., scarring, obstruction, etc.), regardless of whether related to the underlying cancer or disease progression; 5. Clinically significant evidence of notable cardiovascular, renal, hepatic, or psychiatric diseases determined by relevant medical history, clinical laboratory tests, electrocardiogram (ECG) results, and physical examination, which may expose the patient to risk after administration of the study drug or may confound the analysis and/or interpretation of study results; 6. Known or suspected unstable brain metastases or spinal cord compression; 7. Patients with severe neuropathic cancer pain or other refractory cancer pain; 8. Pregnant or breastfeeding women, or patients (including males) who have a fertility plan within 3 months; 9. Subjects who have participated in a clinical study involving a new chemical entity or an investigational drug within 30 days prior to entering this study (defined as the start of the screening period); 10. Other diseases or conditions that, in the opinion of the investigator, preclude enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective pain relief rate at Day 7; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of episodes and duration of pain episodes;Dosage of the pain relief medication for emergency situations;Symptom improvement;Satisfaction with pain control; | — |
Countries
China
Contacts
Public ContactBangwei Cao
Department of Oncology, Beijing Friendship Hospital,Capital Medical University
Outcome results
None listed