L-PZQ ODT in Schistosoma Infected Children

Phase 3 Completed 288 enrolled Merck KGaA, Darmstadt, Germany

RandomizedParallel-groupOpen-labelTreatment

Summary

The study would evaluate the safety and efficacy of L-praziquantel orodispersible (L-PZQ ODT) tablets in Schistosoma infected children aged 3 months to 6 years.

Timeline

Start: 2019-09-02
Primary completion: 2021-10-11
Completion: 2021-10-11

Publications

N'Goran EK, Odiere MR, Assande Aka R, Ouattara M, Aka NAD, Ogutu B, Rawago F, Bagchus WM, Bodding M, Kourany-Lefoll E, Tappert A, Yin X, Bezuidenhout D, Badenhorst H, Huber E, Dalken B, Haj-Ali Saflo O. Efficacy, safety, and palatability of arpraziquantel (L-praziquantel) orodispersible tablets in children aged 3 months to 6 years infected with Schistosoma in Cote d'Ivoire and Kenya: an open-label, partly randomised, phase 3 trial. Lancet Infect Dis. 2023 Jul;23(7):867-876. doi: 10.1016/S1473-3099(23)00048-8. Epub 2023 Mar 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Praziquantel	Small molecule	40 mg/kg	Oral
Subject	arpraziquantel	Small molecule	50 mg/kg	Oral
Subject	arpraziquantel	Small molecule	60 mg/kg	Oral

L-PZQ ODT in Schistosoma Infected Children

Summary

Timeline

Publications

Drugs

Indications