Real World Study of Oxycodone/Naloxone Sustained-Release Tablets (Mimeixin) for Patients With Sev… (NCT06897917) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Real World Study of Oxycodone/Naloxone Sustained-Release Tablets (Mimeixin) for Patients With Severe Cancer Pain
China203 participantsStarted 2025-04
Plain-language summary
This study is a prospective, single-arm, multicenter, real-world study to evaluate effect of bowel function, analgesic effect, quality of life, and safety of Mimeixin® in Chinese patients with severe cancer pain.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years old, with a histological or pathological diagnosis of advanced cancer.
* Be diagnosed with severe (NRS ≥ 7 points) cancer pain, requiring regular opioid therapy.
* Diagnosed with OIC according to the Rome IV diagnostic criteria for OIC, with a BFI score ≥ 30.
* Determined by the investigator to be eligible for treatment with oxycodone/naloxone sustained-release tablets.
* Estimated survival period of more than 3 months.
* Voluntarily sign an informed consent form.
Exclusion Criteria:
* Patients with contraindications to oxycodone/naloxone sustained-release tablets (including allergy to the active ingredients or any excipients of this product; severe respiratory depression accompanied by hypoxemia and/or hypercapnia; severe chronic obstructive pulmonary disease; pulmonary heart disease; severe bronchial asthma; paralytic ileus caused by non-opioid drugs; moderate to severe liver function impairment).
* Patients with structural malformations of the gastrointestinal tract (such as intestinal obstruction, stenosis), other known gastrointestinal diseases/symptoms (including cancer metastasis to the digestive tract), or gastrointestinal digestion and absorption disorders.
* Patients with language communication barriers, cognitive impairments or mental illnesses, intracranial metastasis of tumors with consciousness disorders, or consciousness disorders caused by other reasons.
* Other situations that the investigator judges as unsuitable for i…
What they're measuring
1
Changes of Patients' Bowel Function of day 28
Timeframe: pre-intervention, day 7, day 14, day 21 and day 28 after the intervention