Trial · NCT02315352
Cross-over Study to Evaluate the Palatability of New Orally Disintegrating Tablets (ODTs) of Praziquantel (PZQ) and L-PZQ Versus Current PZQ Tablets in African Children Age 6-11 Years
NCT02315352, Phase 1, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2017-03-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cross-over Study to Evaluate the Palatability of New Orally Disintegrating Tablets (ODTs) of Praziquantel (PZQ) and L-PZQ Versus Current PZQ Tablets in African Children Age 6-11 Years. Trials, record NCT02315352. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02315352
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cross-over Study to Evaluate the Palatability of New Orally Disintegrating Tablets (ODTs) of Praziquantel (PZQ) and L-PZQ Versus Current PZQ Tablets in African Children Age 6-11 Years
- NCT number
- NCT02315352
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 48 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Healthy
- Interventions
- L-PZQ ODT, Rac-PZQ ODT, L-PZQ ODT, Rac-PZQ ODT, Cesol®
- First posted
- 2014-12-11
- Last updated
- 2017-03-06
- Results first posted
- 2017-03-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Palatability Visual Analogue Scale (VAS) Score at 0 Minute (Right After the Spit-out of the Investigational Medicinal Product [IMP]) | 0 minute (Right After the Spit-out of the IMP) | Overall palatability was assessed on a 0 to 100 unit VAS scale, where higher scores indicate better palatability. |
| Secondary | Overall Palatability VAS Score at 2-5 Minutes | 2-5 minutes (After the IMP has been spat out) | Overall palatability was assessed on a 0 to 100 unit VAS scale, where higher scores indicate better palatability. |
| Secondary | Number of Subjects With Mouth Feeling and Taste Description Evaluation | 2-5 minutes (After the IMP has been spat out) | Mouth feeling was described in terms of "sweet", "bitter", "sticky" or "smooth" as per the experience of the subject with the trial medication. |
| Secondary | Number of Subjects With Discomfort or Observations Relating to Acceptance of the Study Medication | 2-5 minutes |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Palatability Visual Analogue Scale (VAS) Score at 0 Minute (Right After the Spit-out of the Investigational Medicinal Product [IMP]) | 0 minute (Right After the Spit-out of the IMP) | The Safety Set (SAF) included all enrolled subjects who received at least 1 dose of any study drug. | units on a scale | MEAN |
| SECONDARY | Overall Palatability VAS Score at 2-5 Minutes | 2-5 minutes (After the IMP has been spat out) | The Safety Set (SAF) included all enrolled subjects who received at least 1 dose of any study drug. | units on a scale | MEAN |
| SECONDARY | Number of Subjects With Mouth Feeling and Taste Description Evaluation | 2-5 minutes (After the IMP has been spat out) | The data for this outcome measure could not be evaluated as data were not collected according to protocol. | ||
| SECONDARY | Number of Subjects With Discomfort or Observations Relating to Acceptance of the Study Medication | 2-5 minutes | The Safety Set (SAF) included all enrolled subjects who received at least 1 dose of any study drug. | Subjects | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Palatability Visual Analogue Scale (VAS) Score at 0 Minute (Right After the Spit-out of the Investigational Medicinal Product [IMP]) | L-PZQ (Without Water) Day 1 | 49.0 | Standard Deviation 33.65 | units on a scale | |
| Overall Palatability Visual Analogue Scale (VAS) Score at 0 Minute (Right After the Spit-out of the Investigational Medicinal Product [IMP]) | Rac-PZQ (Without Water) Day 1 | 39.3 | Standard Deviation 28.43 | units on a scale | |
| Overall Palatability Visual Analogue Scale (VAS) Score at 0 Minute (Right After the Spit-out of the Investigational Medicinal Product [IMP]) | L-PZQ (With Water) Day 2 | 67.5 | Standard Deviation 31.14 | units on a scale | |
| Overall Palatability Visual Analogue Scale (VAS) Score at 0 Minute (Right After the Spit-out of the Investigational Medicinal Product [IMP]) | Rac-PZQ (With Water) Day 2 | 51.4 | Standard Deviation 32.35 | units on a scale | |
| Overall Palatability Visual Analogue Scale (VAS) Score at 0 Minute (Right After the Spit-out of the Investigational Medicinal Product [IMP]) | Cesol® (With Water) Day 2 | 20.3 | Standard Deviation 24.91 | units on a scale | |
| Overall Palatability VAS Score at 2-5 Minutes | L-PZQ (Without Water) Day 1 | 50.7 | Standard Deviation 27.23 | units on a scale | |
| Overall Palatability VAS Score at 2-5 Minutes | Rac-PZQ (Without Water) Day 1 | 45.1 | Standard Deviation 29.62 | units on a scale | |
| Overall Palatability VAS Score at 2-5 Minutes | L-PZQ (With Water) Day 2 | 61.1 | Standard Deviation 21.19 | units on a scale | |
| Overall Palatability VAS Score at 2-5 Minutes | Rac-PZQ (With Water) Day 2 | 50.2 | Standard Deviation 25.92 | units on a scale | |
| Overall Palatability VAS Score at 2-5 Minutes | Cesol® (With Water) Day 2 | 33.5 | Standard Deviation 22.23 | units on a scale |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow120
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (Day 1) | STARTED | L-PZQ Then Rac-PZQ (Day 1) | 24 | |
| First Intervention (Day 1) | STARTED | Rac-PZQ Then L-PZQ (Day 1) | 24 | |
| First Intervention (Day 1) | STARTED | L-PZQ Then Rac-PZQ Then Cesol® (Day 2) | 0 | |
| First Intervention (Day 1) | STARTED | L-PZQ Then Cesol® Then Rac-PZQ (Day 2) | 0 | |
| First Intervention (Day 1) | STARTED | Rac-PZQ Then Cesol® Then L-PZQ (Day 2) | 0 | |
| First Intervention (Day 1) | STARTED | Rac-PZQ Then L-PZQ Then Cesol® (Day 2) | 0 | |
| First Intervention (Day 1) | STARTED | Cesol® Then L-PZQ Then Rac-PZQ (Day 2) | 0 | |
| First Intervention (Day 1) | STARTED | Cesol® Then Rac-PZQ Then L-PZQ (Day 2) | 0 | |
| First Intervention (Day 1) | COMPLETED | L-PZQ Then Rac-PZQ (Day 1) | 24 | |
| First Intervention (Day 1) | COMPLETED | Rac-PZQ Then L-PZQ (Day 1) | 24 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 participant flowAdverse events5
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Malaria | Infections and infestations | L-PZQ (Without Water) Day 1 | 0 | 48 | |
| other | Malaria | Infections and infestations | Rac-PZQ (Without Water) Day 1 | 1 | 48 | |
| other | Malaria | Infections and infestations | L-PZQ (With Water) Day 2 | 0 | 47 | |
| other | Malaria | Infections and infestations | Rac-PZQ (With Water) Day 2 | 0 | 47 | |
| other | Malaria | Infections and infestations | Cesol® (With Water) Day 2 | 0 | 47 |
Source ClinicalTrials.gov
Adverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | L-PZQ (Without Water) Day 1 | ||
| Total, all-cause mortality | Rac-PZQ (Without Water) Day 1 | ||
| Total, all-cause mortality | L-PZQ (With Water) Day 2 | ||
| Total, all-cause mortality | Rac-PZQ (With Water) Day 2 | ||
| Total, all-cause mortality | Cesol® (With Water) Day 2 | ||
| Total, other adverse events | L-PZQ (Without Water) Day 1 | 0 | 48 |
| Total, other adverse events | Rac-PZQ (Without Water) Day 1 | 1 | 48 |
| Total, other adverse events | L-PZQ (With Water) Day 2 | 0 | 47 |
| Total, other adverse events | Rac-PZQ (With Water) Day 2 | 0 | 47 |
| Total, other adverse events | Cesol® (With Water) Day 2 | 0 | 47 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34106922 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02315352
GET https://conductscience.org/api/trials/v1/NCT02315352/flow?page=2