Documentation of a new contrast medium for the subarachnoid space. Demands, design and results from the first...

The first clinical trial with the non-ionic contrast medium iohexol (Omnipaque) in lumbar myelography was performed as a multicentre investigation of a total of 88 included patients. The design of the comprehensive clinical trial program is presented and the necessity of using such an extensive clinical trial program in the early stage of the investigation is discussed. This comprehensive monitoring did not reveal any serious or persistent side effects. The documentation on the safety of the drug encourages further clinical trials.