[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640523":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":31,"collaborators":26,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":26,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":26,"enrollmentInfo":42,"targetDuration":26,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":26,"overallStatus":51,"whyStopped":26,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":26},{"fullName":5,"class":6},"First Affiliated Hospital of Wenzhou Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","Experimental: The dosage of Nintedanib is 150mg\u002F100mg per dose, twice daily；The dosage of Dextromethorphan is 30mg per dose, twice daily.",[13],"Drug: Nintedanib,Dextromethorphan",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","PLACEBO_COMPARATOR","Control group：The dosage of Nintedanib is 150mg\u002F100mg per dose, twice daily；Placebo take orally twice daily.",[19],"Drug: Nintedanib,Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Nintedanib,Dextromethorphan","Dosage of Nitedanib is 150mg\u002F100mg each time, twice a day, once in the morning and once in the evening, It is recommended to take it with meals. The dosage of Dextromethorphan sustained-release tablets is 30 mg, twice a day. It is recommended to take it orally 30 minutes after meals. For 12 weeks.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Nintedanib,Placebo","Dosage of Nitedanib is 150mg\u002F100mg each time, twice a day, once in the morning and once in the evening, with an interval of 12hours. It is recommended to take it with meals to reduce gastrointestinal adverse reactions. Placebo, twice a day, recommended to be taken in the morning and evening. For 12 weeks.",[15],{"type":32,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100640523","phase-2-nintedanib-with-or-without-dextromethorphan-in-patients-with-idiopathic-pulmonary-fibrosis-ipf-100640523",false,"NCT07583589","Nintedanib With or Without Dextromethorphan in Patients With Idiopathic Pulmonary Fibrosis (IPF)","A Multicenter, Randomized, Double Blind, Placebo-controlled Clinical Study to Evaluate the Treatment of Nidanib With or Without Dextromethorphan in Idiopathic Pulmonary Fibrosis (IPF) Patients.","Inclusion Criteria:\n\n1. Age ≥40 years old, regardless of gender;\n2. According to \"2022 ATS\u002FERS\u002FJRS\u002FALAT Guidelines\", it was diagnosed as idiopathic pulmonary fibrosis (IPF);\n3. Lung function meets the following conditions during screening: forced vital capacity (FVC) ≥45% predicted value; The dispersion of carbon monoxide (DLco, corrected Hb) in a single breath is between 30% and 80% of the predicted value.\n4. HRCT images completed within 12 months before screening can be used to determine UIP mode;\n5. It is expected to complete the whole research plan, including 12 weeks of treatment and 1 week of follow-up;\n6. Willing to follow all the requirements of drug use, visit and data collection during the study period;\n7. Be able to understand the research content and sign the written informed consent;\n8. Women of childbearing age provide negative pregnancy test results, and agree to take effective contraceptive measures during the study period and within 3 months after the last administration; Male subjects with fertility also need to take effective contraception at the same time.\n\nExclusion Criteria:\n\n1. Suffering from other interstitial lung diseases caused by non-IPF reasons (such as connective tissue disease-related ILD, chronic allergic pneumonia, pneumoconiosis, drug-induced pneumonia, radiation lung disease, etc.);\n2. One or more Acute Exacerbation)； of IPF occurred within 3 months before screening;\n3. Have received a lung transplant;\n4. Complicated with severe COPD(GOLD III and above), severe asthma or other airway diseases that may interfere with FVC determination;\n5. The following systemic immunosuppressive treatments were used within 4 weeks before screening: \\> 15 mg\u002Fd prednisone (or equivalent dose), cyclophosphamide, methotrexate, tuzumab, rituximab, mycophenolate mofetil, etc.\n6. Currently or in the past, allergic to Nidanib, dextromethorphan or any of its auxiliary ingredients;\n7. The following laboratory abnormalities exist: ALT or AST \\>3×ULN；; eGFR \\\u003C30 mL\u002Fmin\u002F1.73m²；\n8. Have a history of uncontrolled mental illness, epilepsy, central nervous system dysfunction, or may induce adverse reactions after using dextromethorphan;\n9. Being receiving drugs that may have serious drug interaction with dextromethorphan, such as monoamine oxidase inhibitor (MAOI) and selective serotonin reuptake inhibitor (SSRI), and unable to stop taking drugs;\n10. Pregnant or lactating women;\n11. At the time of screening, there are other major diseases or medical conditions that researchers think will significantly increase the risk and affect the treatment compliance or data interpretation;\n12. Interventional treatment of other clinical trials within 4 weeks before screening.\n13. Use Nidanib or pirfenidone for anti-fibrosis treatment within 8 weeks before screening;","ALL","40 Years",{"count":43,"type":44},60,"ESTIMATED","INTERVENTIONAL",[47],"PHASE2","Nintedanib combined with or without Dextromethorphan for the treatment of IPF, with FVC as the primary efficacy endpoint to evaluate its effectivenes.",[50],"Idiopathic Pulmonary Fibrosis (IPF)","NOT_YET_RECRUITING","2026-05-08",{"date":54,"type":55},"2026-05-13","ACTUAL",{"date":57,"type":44},"2026-05-12",{"date":59,"type":44},"2027-06-01",{"name":5,"class":6}]