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Search / Trial NCT06897917

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

Launched by HENAN CANCER HOSPITAL · Mar 26, 2025

Trial Information

Current as of April 23, 2025

Not yet recruiting

Keywords

Opioid Induced Constipation Severe Cancer Pain Oxycodone/Naloxone Sustained Release Tablets

ClinConnect Summary

Cancer remains a significant health concern globally, with rising incidence and mortality rates. In 2022, there were 19.96 million new cancer cases and 9.74 million cancer deaths worldwide, including 4.8 million new cases and 2.6 million deaths in China. Cancer patients often experience pain during treatment, with 40% of patients reporting persistent pain, particularly moderate to severe pain, occurring in 40%-80% of cases. Unrelieved pain can exacerbate symptoms such as anxiety, depression, fatigue, insomnia, and loss of appetite, significantly impacting patients' quality of life. Opioids,...

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.

Trial Officials

Suxia Luo, Doctor

Principal Investigator

Henan Cancer Hospital

About Henan Cancer Hospital

Henan Cancer Hospital, a leading institution in oncology care and research, is dedicated to advancing cancer treatment through innovative clinical trials. With a commitment to improving patient outcomes, the hospital combines cutting-edge medical expertise with state-of-the-art facilities to conduct research that addresses critical gaps in cancer therapy. As a prominent sponsor of clinical trials, Henan Cancer Hospital focuses on developing novel therapeutic approaches and enhancing existing treatment protocols, fostering a collaborative environment that engages both patients and healthcare professionals in the pursuit of improved cancer care.

Locations

Zhengzhou, Henan, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported