Comparison · NCT03845140-191ffdfb
Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg vs Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg: Cohort 1a and Cohort 1b: Number of Participants With Clinical Cure Determined by Kato-Katz Method
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg vs Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg: Cohort 1a and Cohort 1b: Number of Participants With Clinical Cure Determined by Kato-Katz Method. Trial comparisons, record NCT03845140-191ffdfb. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03845140-191ffdfb
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.878 | 0.798 | 0.929 | wilson | |
| Risk in group 2 | 0.813 | 0.681 | 0.898 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0651 | -0.0517 | 0.206 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.08 | 0.925 | 1.26 | log | |
| Odds ratio, group 1 over group 2 | 1.65 | 0.644 | 4.25 | log | |
| Number needed to treat, for one more participant with the outcome on Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg than on Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | 15.4 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg | Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1. | 86 | 98 | OG000 |
| Group 2 | Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg | Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1. | 39 | 48 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Cohort 1a and Cohort 1b: Number of Participants With Clinical Cure Determined by Kato-Katz Method
- Description
- Clinical cure was defined as no parasite egg in the stool at Week 3 as determined by the Kato-Katz method. Number of participants with clinical cure were reported.
- Time frame
- at Week 3
- Population
Modified intent to treat analysis population (mITT) included all enrolled participants who received one dose of treatment and had baseline measurement, excluding those who used anti-malaria treatment after enrollment. Only 1 participant from Cohort 1b was lost to follow-up and was imputed as non-cured.
Source ClinicalTrials.gov
Trial
- Title
- L-PZQ ODT in Schistosoma Infected Children
- NCT number
- NCT03845140
- Phases
- PHASE3
- Conditions
- Schistosomiasis
- Interventions
- L-PZQ ODT 50 mg/kg, Biltricide®, L-PZQ ODT 60 mg/kg
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Results first posted
- 2024-03-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03845140?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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