Status:
NOT_YET_RECRUITING
Real World Study of Oxycodone/Naloxone Sustained-Release Tablets (Mimeixin) for Patients With Severe Cancer Pain
Lead Sponsor:
Henan Cancer Hospital
Conditions:
Opioid-Induced Constipation
Pain Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT06897917
Start Date
April 1 2025
End Date
December 1 2025
Last Update
March 27 2025
Active Locations (1)
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1
Henan Cancer Hospital
Zhengzhou, Henan, China