Phase III clinical trials with praziquantel in S. japonicum infections in the Philippines.

Following successful Phase II clinical studies with praziquantel (2-cyclohexylcarbonyl-1,2,3,6,7,11b-hexahydro-4H-pyrazino [2,1-a]isoquinolin-4-one, EMBAY 8440, Biltricide), expanded field trials of Phase III were conducted in Mindoro Oriental, Leyte and Davao Norte, to reassess efficacy, safety and acceptability of the drug on a larger scale. A total of 6,134 cases were treated with the best tolerated and effective dose of 60 mg/kg bwt which for practical purposes was given in 2 instead of 3 divided doses as applied in the earlier trials. Two aliquots of one stool from each individual were examined quantitatively by a modification of the thick smear method one week before, six and twelve months after treatment.