[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cancer-palliative-care\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cancer-palliative-care":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100646692","phase-3-efficacy-of-non-opioid-drugs-in-addition-to-opioid-therapy-for-cancer-pain-management-100646692",false,"NCT07682558","Efficacy of Non-opioid Drugs in Addition to Opioid Therapy for Cancer Pain Management","Efficacy of Non-opioid Drugs in Addition to Opioid Therapy for Cancer Pain Management: a Double-blind, Randomized, Three Arm, Placebo Controlled Trial Assessing the Key Non-opioids Dipyrone (Metamizole) and Ibuprofen","NoDoubt","Inclusion Criteria:\n\n* Inpatient setting (discharge possible, if patient returns for End of Study Visit)\n* Diagnosis of metastatic or locally advanced cancer\n* Cancer pain as defined by IASP (International Association for the Study of Pain)\n* Cancer pain therapy with opioids indicated for pain management or start thereof at baseline (drug, dose, and route at treating physician's discretion)\n* Average daily pain intensity ≥ 3 on NRS (Numeric Rating Scale)\n* Ability to swallow oral medication\n* Informed Consent as documented by signature\n\nExclusion Criteria:\n\n* History of allergy or allergy-like symptoms (bronchospasm, urticaria or severe cutaneous adverse reactions (SCARs)) or hypersensitivity to dipyrone (or other pyrazolones or pyrazolidines) or ibuprofen (or other Non-steroidal anti-inflammatory drug incl. acetylsalicylic acid)\n* Moderate to severe renal insufficiency (creatinine-eGFR (estimated Glomerular Filtration Rate) \\\u003C45 ml\u002Fmin)\n* Severe heart failure (New York Heart Association class III-IV)\n* Severe hepatic impairment (liver cirrhosis with ascites) or hepatic porphyria\n* History of agranulocytosis induced by dipyrone (or other pyrazolones or pyrazolidines)\n* Active gastric and\u002For duodenal ulcers or bleeding\n* History of recurrent gastric and\u002For duodenal ulcers or gastrointestinal bleeding (≥2 distinct episodes of proven ulceration or bleeding) or increased tendency to bleeding\n* Third trimester of pregnancy\n* Breastfeeding\n* G6PD deficiency\n* Inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)\n* Intrathecal or epidural opioids or local or regional anesthetic therapy\n* Additional second opioid for co-analgesic effects or other reasons (e.g., methadone, buprenorphine)\n* Initiation of therapy with transdermal therapeutic system (TTS) opioid \\\u003C48 hours before start of IMP\n* Use of non-opioids with long half-life (i.e., acemetacin, celecoxib, etodolac, etoricoxib, ketorolac, naproxen, piroxicam, tenoxicam)\n* Pain unrelated to cancer (e.g. chronic non-cancer pain \\[CNCP\\], postoperative, particularly following coronary artery or cardiopulmonary bypass surgery)\n* Inability to follow study procedures or adhere to protocol (e.g., due to language problems, psychological disorders, dementia)\n* Inability to abstain from other non-opioids (apart from IMP (Investigational Medicinal Product)) during study participation\n* Participation in any interventional study targeted at pain management\n* Participant is a family member or employee of the investigator","ALL","18 Years",{"count":20,"type":21},318,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The investigators investigate the efficacy of non-opioid analgesics compared to placebo together with opioid therapy for cancer pain management.",[27,28],"Cancer Pain","Cancer Palliative Care","NOT_YET_RECRUITING","2026-08-18",{"date":32,"type":33},"2026-08-19","ACTUAL",{"date":35,"type":21},"2026-10",{"date":37,"type":21},"2029-11",{"name":39,"class":40},"University Hospital, Basel, Switzerland","OTHER"]