{"id":"oros-hydromorphone-hcl-morphine-sulfate","safety":{"commonSideEffects":[{"rate":null,"effect":"Constipation"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Somnolence"},{"rate":null,"effect":"Vomiting"},{"rate":null,"effect":"Headache"}]},"_chembl":{"chemblId":"CHEMBL2103744","moleculeType":"Small molecule","molecularWeight":"758.84"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Hydromorphone is a semi-synthetic opioid that activates mu opioid receptors, inhibiting pain signal transmission and modulating pain perception. The OROS (osmotic release oral system) technology provides controlled, extended-release delivery over 24 hours, maintaining steady-state plasma concentrations and reducing dosing frequency. Morphine sulfate is also included as a reference comparator, being a natural opioid alkaloid with similar mu receptor agonist activity.","oneSentence":"OROS hydromorphone HCl is an extended-release opioid agonist that binds to mu opioid receptors in the central nervous system to provide prolonged pain relief.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:24:54.861Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Moderate to severe chronic pain requiring continuous opioid therapy"}]},"trialDetails":[{"nctId":"NCT01824524","phase":"PHASE1","title":"A Pharmacokinetic and Safety Study of Osmotic Release Oral System (OROS) Hydromorphone in Non-Opioid Tolerant Chinese Participants With Cancer","status":"COMPLETED","sponsor":"Xian-Janssen Pharmaceutical Ltd.","startDate":"2011-12","conditions":"Pain","enrollment":12},{"nctId":"NCT00261495","phase":"PHASE3","title":"A Study of the Effectiveness and Safety of Sustained-release Hydromorphone (a Strong Opioid) in Patients With Chronic Noncancer Pain.","status":"COMPLETED","sponsor":"Janssen Pharmaceutica N.V., Belgium","startDate":"2006-03","conditions":"Pain","enrollment":504},{"nctId":"NCT01205126","phase":"PHASE3","title":"An Efficacy and Safety Study of Oral Osmotic Therapeutic System (OROS) Hydromorphone Hydrochloride (HCl) in Participants With Cancer Related Pain","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2009-12","conditions":"Pain","enrollment":260},{"nctId":"NCT00766831","phase":"PHASE4","title":"An Efficacy and Safety Study of Hydromorphone Oral Osmotic System (OROS) in Korean Participants With Cancer Pain","status":"COMPLETED","sponsor":"Janssen Korea, Ltd., Korea","startDate":"2008-10","conditions":"Cancer Pain","enrollment":190},{"nctId":"NCT01648699","phase":"PHASE4","title":"Safety and Efficacy Study of Osmotic Release Oral System (OROS) Hydromorphone in Participants With Cancer Pain","status":"TERMINATED","sponsor":"Janssen Pharmaceutica","startDate":"2010-04","conditions":"Pain","enrollment":20},{"nctId":"NCT00803283","phase":"PHASE3","title":"A Study to Compare Safety and Efficacy of Osmotic Release Oral Syytem (OROS) Hydromorphone Hydrochloride (HCl) With Morphine Sustain Release (SR) in Participants With Cancer Pain","status":"TERMINATED","sponsor":"Johnson & Johnson Taiwan Ltd","startDate":"2008-11","conditions":"Cancer Pain","enrollment":2},{"nctId":"NCT01487564","phase":"PHASE1","title":"Pharmacokinetic Profile of OROS Hydromorphone in Healthy Taiwanese Participants With Different Genotypes for the UGT2B7 Gene","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2011-10","conditions":"Healthy Volunteers","enrollment":29},{"nctId":"NCT00410540","phase":"PHASE3","title":"A Study of OROS Hydromorphone HCL vs Morphine in Cancer Pain Patients.","status":"COMPLETED","sponsor":"Alza Corporation, DE, USA","startDate":"","conditions":"Pain, Analgesics, Opioid","enrollment":202},{"nctId":"NCT00399048","phase":"PHASE3","title":"An Effectiveness, Safety and Quality of Life Measures With Hydromorphone HCL, Dilaudid CR (Controlled Release)","status":"COMPLETED","sponsor":"Alza Corporation, DE, USA","startDate":"","conditions":"Osteoarthritis, Knee, Osteoarthritis, Hip","enrollment":140}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"OROS hydromorphone HCL ; Morphine sulfate","genericName":"OROS hydromorphone HCL ; Morphine sulfate","companyName":"Alza Corporation, DE, USA","companyId":"alza-corporation-de-usa","modality":"Small molecule","firstApprovalDate":"","aiSummary":"OROS hydromorphone HCl is an extended-release opioid agonist that binds to mu opioid receptors in the central nervous system to provide prolonged pain relief. Used for Moderate to severe chronic pain requiring continuous opioid therapy.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}