Clinical trial · Interventional
Real World Study of Oxycodone/Naloxone Sustained-Release Tablets (Mimeixin) for Patients With Severe Cancer Pain
NCT06897917CI-TRIAL-00087750not yet recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Opioid-Induced Constipation | — | UNRESOLVED | — |
| Pain Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxycodone Hydrochloride and Naloxone Hydrochloride Sustained-release Tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oxycodone/naloxone sustained-release tablets treatment group
- description
- Patients receiving oxycodone naloxone sustained-release tablets were included in the study cohort.
- interventionNames
- Drug: Oxycodone Hydrochloride and Naloxone Hydrochloride Sustained-release Tablets
Primary outcomes (1)
- measure
- Changes of Patients' Bowel Function of day 28
- timeFrame
- pre-intervention, day 7, day 14, day 21 and day 28 after the intervention
- description
- 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.
Secondary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.