Phase II studies in urography, cardioangiography and cerebral angiography with iohexol. An evaluation of the clinical trial program and the clinical findings.
The first experience in patients (phase II studies) with iohexol (Omnipaque) - a new non-ionic contrast medium - in intravenous urography (34 patients), cardioangiography (45 patients) and cerebral angiography (38 patents) is collectively reported. A non-comparative, multicentre design was used in all 3 applications. The objective was to assess the efficacy (the opacity to X-rays) and the tolerability of iohexol using routine contrast medium doses in a well defined adult population. No unexpected or severe reactions occurred in the 117 included or 9 excluded patients. Good efficacy was confirmed, and the contrast medium was well tolerated. The results warrant advancing iohexol into comparative phase III trials. The iohexol phase II studies and initial research in patients with contrast media in general are discussed.
D000293:Adolescent; D000328:Adult; D000368:Aged; D000790:Angiocardiography; D002533:Cerebral Angiography; D003287:Contrast Media / Q000633:toxicity; D003718:Denmark; D004341:Drug Evaluation / Q000379:methods / Q000592:standards; D006801:Humans; D007391:International Cooperation; D007463:Iodobenzoates / Q000633:toxicity; D007472:Iohexol; D008875:Middle Aged; D009664:Norway; D012107:Research Design / Q000592:standards; D013548:Sweden; D014283:Triiodobenzoic Acids / Q000633:toxicity; D014567:Urography
D003287:Contrast Media; D007463:Iodobenzoates; D014283:Triiodobenzoic Acids; D007472:Iohexol