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Phase 4

NCT06897917

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

Sponsored by Henan Cancer Hospital

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.

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.

Locations (1)

Henan Cancer Hospital

Zhengzhou, Henan, China

Why you can trust this information
Registry sourcesclinicaltrials_gov
Source last updated3/27/2025
Clintriva indexed9/27/2026, 9:24:19 PM
Registry records1
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Identity-resolution confidence concerns registry/entity resolution and does not determine clinical eligibility.

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Quick Facts
Start DateApr 1, 2025
CompletionDec 1, 2025
Enrollment0/203
CountryChina

Conditions

Opioid-Induced Constipation
Pain Cancer
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