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

NCT06897917 | Not Yet Recruiting Phase 4

• 1 other identifier: MMX-RWS-01
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

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 cancer pain.

Conditions

Opioid-Induced Constipation; Pain Cancer

Keywords

opioid-induced constipation; severe cancer pain; Oxycodone/naloxone sustained-release tablets

Outcome Measures

Primary Outcomes (1)

• Changes of Patients' Bowel Function of day 28

  The BFI score was used for evaluation, and the data were repeatedly measured. A one-way repeated measures ANOVA model was used, which included follow-up time and baseline BFI values; the variation curve of BFI with follow-up time was also plotted. The analytical method for repeatedly measured data of secondary endpoints was consistent with the primary analytical method.

  pre-intervention, day 7, day 14, day 21 and day 28 after the intervention

Secondary Outcomes (10)

• Changes of Cancer Pain with NRS

  through study completion, an average of 4 weeks

• Changes of Cancer Pain with BPI-SF

  through study completion, an average of 4 weeks

• Changes of breakthrough pain

  within 24 hours

• Frequency of bowel movements and CSBMs

  through study completion, an average of 4 weeks

• Laxative Use

  through study completion, an average of 4 weeks

Study Arms (1)

Oxycodone/naloxone sustained-release tablets treatment group

EXPERIMENTAL

Patients receiving oxycodone naloxone sustained-release tablets were included in the study cohort.

Drug: Oxycodone Hydrochloride and Naloxone Hydrochloride Sustained-release Tablets

Interventions

Oxycodone Hydrochloride and Naloxone Hydrochloride Sustained-release Tablets DRUG

1. Calculate the total opioid dosage administered to the patient in the previous 24 hours and convert it to an equivalent dose of oxycodone/naloxone sustained-release tablets(Mimeixin). 2. Based on the principle of incremental dosing, calculate the total dosage to be administered on the day of enrollment, divide it into two portions, and administer one portion every 12 hours (q12h). 3. In case of breakthrough pain during treatment, administer an equivalent dose of immediate-release morphine or other medications equivalent to 10%-20% of the 24-hour background dosing for relief. 4. If the number of breakthrough pain events exceeds 2 in a day after dosing, adjust the dosage again based on the incremental dosing principle. Adjustments should be made every 1-2 days, with each adjustment increasing the dose by a gradient of 5 mg/2.5 mg or 10 mg/5 mg of oxycodone/naloxone sustained-release tablets, twice daily, and so on. The maximum daily dose of oxycodone should not exceed 160 mg.

Also known as: Mimeixin

Oxycodone/naloxone sustained-release tablets treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Opioid-Induced Constipation; Cancer Pain

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Constipation; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Suxia Luo, Doctor

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suxia Luo, Doctor

CONTACT

8618638553211; luosxrm@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 27, 2025
• Study Start: April 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)