At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 288 enrolled
Drug / intervention
L-PZQ ODT 50 mg/kg +2 moredrug
Likely dose
L-PZQ ODT 50 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label, Phase III Efficacy and Safety Study of L-PZQ ODT in Schistosoma Infected Children 3 Months to 6 Years of Age, Including a 2:1 Randomized, Controlled Cohort of Schistosoma Mansoni Infected Children 4 to 6 Years of Age Treated With L PZQ ODT or Commercial PZQ (Biltricide®)
In Brief
A Phase 3 clinical trial evaluating L-PZQ ODT 50 mg/kg, Biltricide®, and 1 other intervention for Schistosomiasis. Completed, enrolled 288 participants across 2 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchistosomiasis
CountriesCôte d’Ivoire, Kenya
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedFeb 2019
Enrollment StartSep 2019
Primary CompletionOct 2021
TodayJul 2026
First PostedFeb 19, 2019
Enrollment StartSep 2, 2019
Primary CompletionOct 11, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 7.4 years ago
Interventions
L-PZQ ODT 50 mg/kgdrug
Participants received single oral dose of L-PZQ ODT 50 mg/Kg on Day 1.
Biltricide®drug
Participants received single oral dose of Biltricide® 40 mg/kg on Day 1.
L-PZQ ODT 60 mg/kgdrug
Participant received single oral dose of L-PZQ ODT 60 mg/kg on Day 1.