Open-label, Dose-finding, 2-parts, Efficacy Phase II Study With Three Formulations (Racemate Praziquantel Commercial Oral Tablets, New Oral Disintegrating Tablets of Racemate Praziquantel and L-praziquantel) in Schistosomiasis (S. Mansoni) Infected Children Aged 2-6 Years (Part 1), Followed by an Assessment of Efficacy and Safety With the Selected Formulation and Dosage in S. Mansoni Infected Infants Aged 3-24 Months (Part 2a) and in Children Aged 2-6 Years Infected With S. Haematobium (Optional) (Part 2b)
Phase of Trial: Phase II
Latest Information Update: 02 Nov 2017
At a glance
- Drugs Praziquantel (Primary)
- Indications Schistosomiasis
- Focus Therapeutic Use
- Sponsors Merck KGaA
- 27 Oct 2017 Planned number of patients changed from 520 to 460.
- 27 Sep 2017 Planned End Date changed from 30 Jun 2017 to 30 Jun 2018.
- 27 Sep 2017 Planned primary completion date changed from 30 Jun 2017 to 30 Jun 2018.