moderate to severe chronic cancer pain
Conditions
Interventions
Group A:Oxycodone and naloxone sustained-release tablets
Group B:Oxycodone sustained-release tablets
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients aged >=18 years, male or female, with malignancy confirmed by histopathological or cytological examination. 2.Previous diagnosis of moderate to severe chronic cancer pain (opioid-tolerant patients with NRS >= 4), requiring continuous (AROUND THE CLOCK) opioid medication (with an initial opioid dose equivalent to 20-80mg/day of oxycodone), and And patients who could benefit from WHO III step opioid treatment throughout the study. 3. Diagnosed with opioid-induced constipation according to the Rome IV criteria. 4. Estimated survival period of more than 3 months. 5.Voluntary participation and signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Contraindications to Oxycodone and naloxone sustained-release tablets and oxycodone prolonged-release tablets (including: hypersensitivity to the active ingredient or any of the excipients; severe respiratory depression with hypoxemia and/or hypercapnia; severe chronic obstructive pulmonary disease; cor pulmonale; severe bronchial asthma; non-opioid-induced paralytic ileus; moderate to severe hepatic impairment). 2.Patients with intestinal obstruction/ileus or perforation are to be excluded; patients with gastrointestinal tumors or gastrointestinal metastases from malignancies who have experienced significant gastrointestinal symptoms within 2 weeks prior to the screening period, such as inability to swallow, refractory nausea and vomiting, chronic diarrhea, constipation, or conditions that may affect drug intake/transport/absorption, are also to be excluded. 3.Patients with language/communication barriers; cognitive impairment or psychiatric disorders; or patients with intracranial metastases from malignancies and impaired consciousness; or impaired consciousness due to other causes. 4.Clinically significant cardiovascular, renal, hepatic, or psychiatric diseases, as well as clinically significant abnormalities in laboratory tests, electrocardiogram (ECG) results, and physical examination findings, such as: aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (?-GGT), or alkaline phosphatase levels >3× the upper limit of normal (ULN), and/or abnormal total bilirubin and/or creatinine levels >1.5× ULN. 5.Pregnant or lactating women, or patients who are unable to practice effective contraception during the study period. 6.Patients who have received antitumor therapy within 2 weeks prior to the screening period through the study treatment period that may affect pain or defecation during this period (however, antitumor therapy that does not affect pain or defecation during this period is permitted, such as stable immunotherapy, targeted therapy, or endocrine antitumor therapy); patients who have undergone surgical treatment within 4 weeks prior to the screening period through the treatment period. 7.Patients who have received naloxone within <=30 days prior to the start of screening. 8.Patients currently participating in another clinical study. 9.Other conditions deemed unsuitable for inclusion by the investigator's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in bowel function at week 1;Analgesic effect at 1 week; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in bowel function over 2 to 4 weeks;Frequency of bowel movements, completely spontaneous bowel movements, and use of laxatives;Analgesic Effect;Improvement in breakthrough pain;Evaluation of withdrawal symptoms;Safety Evaluation;Improvement in quality of life; | — |
Countries
China
Contacts
Public ContactLin Rongbo
Department of Gastrointestinal Oncology, Fujian Cancer Hospital
Outcome results
None listed