PROPOSED CLINICAL DEVELOPMENT

IQB (Instituto de Investigación y Desarrollo Químico-Biológico) on the behalf of Laboratorios INIBSA, the sponsor of the project of development of IQB-9302 as a new local anesthetic has designed a number of phase I, phase II and phase III clinical trials involving more than 1.400 volunteers/patients.

The full description of these clinical trials may be found in the IQB-9302 Project Server, a WEB-site at the INTERNET located at the URL: http://www.iqb.es/ciprocaine/default.htm. In summary this WEB-site contains protocols of the following clinical trials:
 

Project Job Number Phase/reference drug/route Number of patients/volunteers
Job-040 I/bupivacaine/intradermal 12+12
Job-041 I/infiltration 12
Job-042 I/intravenous 16
Job-043 I/bupivacaine/spinal 12
Job-044 I/intravenous 12
Job-045 I/epidural 45
Job-046 I/mepivaine/bupivacaine/epidural 30
Job-047 I/epidural 15
Job-048 I/infiltration 40
Job-049 I/infiltration 12
Job-050 II/bupivacaine/infiltration 160
Job-051 II/bupivacaine/infiltration 24+24
Job-052 II/infiltration 90
Job-053 II/bupivacaine/epidural 60
Job-054 II/epidural 120
Job-055 II/infiltration 80
Job-056 II/spinal 40
Job-057a III/epidural-spinal labour 200
Job-057b III/infiltration dentistry 250
Job-057c III/infiltration surgery 100
Job-057d III/epidural surgery 150

Outlines of these protocols can be obtained (in PDF format)

 PROJECT HOMEPAGE