Real World Study of Oxycodone/Naloxone Sustained-Release Tablets (Mimeixin) for Patients With Severe Cancer Pain

Launched by HENAN CANCER HOSPITAL · Mar 26, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Mimeixin, which is a combination of oxycodone and naloxone, to help manage severe pain in patients with advanced cancer. The trial aims to see how well this medication works for controlling pain, improving bowel function, and enhancing quality of life for patients, while also keeping an eye on safety. It will be conducted in various locations and is looking for participants who are at least 18 years old, have been diagnosed with advanced cancer and severe pain, and are also experiencing constipation caused by opioid medications.

To be eligible for this study, participants must have a significant level of pain (rated 7 or higher on a scale) and have been diagnosed with opioid-induced constipation. Interested individuals will need to provide consent to join the study. Throughout the trial, participants can expect to receive the medication and be monitored for its effects on their pain and overall well-being. It's important to note that there are specific health conditions that would exclude someone from participating, such as severe breathing issues or certain gastrointestinal problems. Overall, this study aims to provide valuable insights into a new treatment option for managing pain and related symptoms in cancer patients.

Gender

ALL

Eligibility criteria

• 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 inclusion in the study.