Clinical trials with iotrolan in myelographic and computed tomography applications in the United States.

Abstract

Iotrolan, a new nonionic contrast agent, was studied in the United States using 190 mg I/ml, 240 mg I/ml, and 300 mg I/ml concentrations. Procedures performed were lumbar, thoracic, cervical, and total columnar myelography and computed tomography applications. Two multicenter double-blind studies (iotrolan versus metrizamide in 190 mg I/ml and 240 mg I/ml concentrations) and five open-label studies were conducted in a total of 863 patients (569 iotrolan, 294 metrizamide). Iotrolan and metrizamide both demonstrated diagnostic efficacy. Iotrolan demonstrated better patient tolerance in comparison with metrizamide.