Biomaterial Database

Ioversol in intravenous excretory urography. Evaluation of radiographic quality, patient tolerance and safety in four clinical studies. 1992

H Jahn, and R Müller-Späth

Scientific Department, Mallinckrodt Medical GmbH, Hennef, Germany.

Three randomized, parallel group, double-blind clinical trials (Study A, B and C) and one open-label, noncomparative clinical trial (Study D) were performed in adult patients to evaluate the radiographic quality, patient tolerance and safety of Optiray 300 (ioversol) in intravenous excretory urography. Comparative agents were iohexol (Study A and C) and iopamidol (Study B). Regarding the radiographic quality ioversol provided a statistically significant better ureter opacification (p = 0.029) compared to iohexol (Study A). In comparison to iopamidol (Study B) the mean degree of certainly with respect to the investigator's urogram-based diagnoses was statistically significant higher (p = 0.025) for ioversol. In these two studies the enhancement quality of regions visualized was higher in the ioversol groups than in the control groups. Regions investigated were: parenchyma, calyces, pelvis, ureters and the bladder. Ioversol, iohexol and iopamidol were found to be statistically comparable with regard to safety and patient tolerance. The results of these studies demonstrate that ioversol is an effective, well tolerated and safe contrast agent for intravenous excretory urography.

UI	MeSH Term	Description	Entries
D006979	Hyperthermia, Induced	Abnormally high temperature intentionally induced in living things regionally or whole body. It is most often induced by radiation (heat waves, infra-red), ultrasound, or drugs.	Fever Therapy,Hyperthermia, Local,Hyperthermia, Therapeutic,Thermotherapy,Induced Hyperthermia,Therapeutic Hyperthermia,Therapy, Fever,Local Hyperthermia
D007275	Injections, Intravenous	Injections made into a vein for therapeutic or experimental purposes.	Intravenous Injections,Injection, Intravenous,Intravenous Injection
D007472	Iohexol	An effective non-ionic, water-soluble contrast agent which is used in myelography, arthrography, nephroangiography, arteriography, and other radiographic procedures. Its low systemic toxicity is the combined result of low chemotoxicity and low osmolality.	Compound 545,Exypaque,Iohexol 350,Nycodenz,Omnipaque
D007479	Iopamidol	A non-ionic, water-soluble contrast agent which is used in myelography, arthrography, nephroangiography, arteriography, and other radiological procedures.	B-15,000,B-15000,Gastromiro,Iopamidol, (+-)-Isomer,Iopamidol, (R)-Isomer,Iopamidol, Sodium Salt, (S)-Isomer,Iopamiro,Isovue,Isovue 370,Jopamidol,Niopam,SQ 13,396,Solutrast,Solutrast 370,Solutrast Gastro,B 15,000,B 15000,B15,000,B15000
D008297	Male		Males
D008875	Middle Aged	An adult aged 45 - 64 years.	Middle Age
D003287	Contrast Media	Substances used to allow enhanced visualization of tissues.	Radiopaque Media,Contrast Agent,Contrast Agents,Contrast Material,Contrast Materials,Radiocontrast Agent,Radiocontrast Agents,Radiocontrast Media,Agent, Contrast,Agent, Radiocontrast,Agents, Contrast,Agents, Radiocontrast,Material, Contrast,Materials, Contrast,Media, Contrast,Media, Radiocontrast,Media, Radiopaque
D004311	Double-Blind Method	A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.	Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260	Female		Females
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man