[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585096":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":32,"responsibleParty":46,"collaborators":30,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":30,"eligibilityCriteria":53,"healthyVolunteers":50,"sex":54,"minAge":55,"maxAge":30,"enrollmentInfo":56,"targetDuration":30,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":70,"whyStopped":30,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Henan Cancer Hospital","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Oxycodone\u002Fnaloxone sustained-release tablets treatment group","EXPERIMENTAL","Patients receiving oxycodone naloxone sustained-release tablets were included in the study cohort.",[13],"Drug: Oxycodone Hydrochloride and Naloxone Hydrochloride Sustained-release Tablets",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Oxycodone Hydrochloride and Naloxone Hydrochloride Sustained-release Tablets","1. Calculate the total opioid dosage administered to the patient in the previous 24 hours and convert it to an equivalent dose of oxycodone\u002Fnaloxone sustained-release tablets(Mimeixin).\n2. 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).\n3. 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.\n4. 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\u002F2.5 mg or 10 mg\u002F5 mg of oxycodone\u002Fnaloxone sustained-release tablets, twice daily, and so on. The maximum daily dose of oxycodone should not exceed 160 mg.",[9],[21],"Mimeixin",[23],{"name":24,"affiliation":5,"role":25},"Suxia Luo, Doctor","PRINCIPAL_INVESTIGATOR",[27],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","8618638553211",null,"luosxrm@163.com",[33],{"facility":5,"status":30,"city":34,"state":35,"zip":30,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Zhengzhou","Henan","China","CN",{"type":39,"coordinates":40},"Point",[41,42],113.64861,34.75778,{"lat":42,"lon":41},[45],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},{"type":47,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100585096","phase-4-real-world-study-of-oxycodonenaloxone-sustained-release-tablets-mimeixin-for-patients-with-severe-cancer-pain-100585096",false,"NCT06897917","Real World Study of Oxycodone\u002FNaloxone Sustained-Release Tablets (Mimeixin) for Patients With Severe Cancer Pain","Inclusion Criteria:\n\n* Age ≥ 18 years old, with a histological or pathological diagnosis of advanced cancer.\n* Be diagnosed with severe (NRS ≥ 7 points) cancer pain, requiring regular opioid therapy.\n* Diagnosed with OIC according to the Rome IV diagnostic criteria for OIC, with a BFI score ≥ 30.\n* Determined by the investigator to be eligible for treatment with oxycodone\u002Fnaloxone sustained-release tablets.\n* Estimated survival period of more than 3 months.\n* Voluntarily sign an informed consent form.\n\nExclusion Criteria:\n\n* Patients with contraindications to oxycodone\u002Fnaloxone sustained-release tablets (including allergy to the active ingredients or any excipients of this product; severe respiratory depression accompanied by hypoxemia and\u002For 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).\n* Patients with structural malformations of the gastrointestinal tract (such as intestinal obstruction, stenosis), other known gastrointestinal diseases\u002Fsymptoms (including cancer metastasis to the digestive tract), or gastrointestinal digestion and absorption disorders.\n* Patients with language communication barriers, cognitive impairments or mental illnesses, intracranial metastasis of tumors with consciousness disorders, or consciousness disorders caused by other reasons.\n* Other situations that the investigator judges as unsuitable for inclusion in the study.","ALL","18 Years",{"count":57,"type":58},203,"ESTIMATED","INTERVENTIONAL",[61],"PHASE4","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.",[64,65],"Opioid-Induced Constipation","Pain Cancer",[67,68,69],"opioid-induced constipation","severe cancer pain","Oxycodone\u002Fnaloxone sustained-release tablets","NOT_YET_RECRUITING","2025-03-26",{"date":73,"type":74},"2025-03-27","ACTUAL",{"date":76,"type":58},"2025-04",{"date":78,"type":58},"2025-12",{"name":5,"class":6},1]