Phase III (BA 2002/01/02) Pivotal Study, Oropharyngeal
Candidiasis in Head and Neck cancer patients (completed)
A comparative noninferiority study conducted at 36 clinical
sties in Europe and North Africa. This study was an open-label,
multicenter, randomized, controlled Phase III study in 308 patients
with head and neck cancer treated by irradiation. In this study,
50 mg miconazole Lauriad® Bioadhesive Buccal Tablets were
compared with miconazole gel, which is marketed in Europe for
the treatment of oropharyngeal candidiasis.