Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Swiss Tropical & Public Health Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of the trial is to compare the "overall palatability" of the new orally disintegrating L-Praziquantel (L-PZQ ODT), the new racemate PZQ ODT (Rac-PZQ ODT) and the current available racemate PZQ tablets (reference) as assessed by means of human gustatory sensation tests (100 millimeter [mm] visual analogue scale [VAS] scoring modified by the incorporation of a 5 point facial hedonic scale).
The secondary objectives are
Initially pupils will be invited with their parents to school where they will be asked to give consent/assent in to the study and they will be instructed on how to follow up the taste study procedures. Enrollments will occur in the health facilities in Ikwiriri/Kibiti at the end of successive training. Informed consent from parents and guardians and assent from the child will be obtained before participation in the study. The study will be conducted in school children 6 years and older as recommended by the Committee for medical product for human use (CHMP) reflection paper: formulations of choice for the pediatric population.
-This is a randomized, five-period cross over, single center swill and spit taste study where the drug will not be swallowed but will be spit out after tasting.
On Day 1, the subjects will assess the palatability of the following arms in a randomized sequence:
On Day 2, the subjects will assess the palatability of the following arms in a randomized sequence:
Gustatory sensation studies will be performed on the different formulations immediately after tasting and 2-5 min after the study drug has been spat out.
All volunteers will be asked to place a mark along the line with the use of a 100 mm visual analogue scale (VAS) that incorporates a 5 points hedonic scale for "overall palatability".
In addition, any discomfort or other observation in relation to acceptance of the study medication (Example: spitting out of the medicine) will be reported by the parents or investigator.
An open ended questionnaire (description of mouth feeling and taste description) will be conducted for each child during the washout period. After the trial a therapeutic dose of Praziquantel will be made available to the local health council and management team to provide to the participating school.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 and 2 | Experimental | A-B or B-A where A: L-PZQ ODT (MSC 2499550A) put on tongue; B: Rac-PZQ ODT (MSC1028703A) put on the tongue |
|
| Period 3, 4 and 5 | Experimental | C-D-E; C-E-D; D-E-C; D-C-E; E-C-D; E-D-C where C: L-PZQ ODT (MSC 2499550A) dispersed in water; D: Rac-PZQ ODT (MSC1028703A) dispersed in water; E: Cesol® 150 mg crushed in water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-PZQ ODT | Drug | L-PZQ ODT (MSC2499550A) tablet at a dose of 150 milligram (mg) put and disintegrated in the mouth without water |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Palatability Visual Analogue Scale (VAS) Score at 0 Minute (Right After the Spit-out of the Investigational Medicinal Product [IMP]) | Overall palatability was assessed on a 0 to 100 unit VAS scale, where higher scores indicate better palatability. | 0 minute (Right After the Spit-out of the IMP) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Palatability VAS Score at 2-5 Minutes | Overall palatability was assessed on a 0 to 100 unit VAS scale, where higher scores indicate better palatability. | 2-5 minutes (After the IMP has been spat out) |
| Number of Subjects With Mouth Feeling and Taste Description Evaluation |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ifakara Health Institute | Ikwiriri | Rufiji | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | CHMP. (2005). Reflection paper: formulation of choice for the paediatric population. EMA | ||
| 34106922 | Derived | Mahende MK, Huber E, Kourany-Lefoll E, Ali A, Hayward B, Bezuidenhout D, Bagchus W, Kabanywanyi AM. Comparative palatability of orally disintegrating tablets (ODTs) of Praziquantel (L-PZQ and Rac-PZQ) versus current PZQ tablet in African children: A randomized, single-blind, crossover study. PLoS Negl Trop Dis. 2021 Jun 9;15(6):e0007370. doi: 10.1371/journal.pntd.0007370. eCollection 2021 Jun. |
Not provided
Not provided
This was a swill and spit taste study where the drug was not swallowed but spit out after tasting. Gustatory sensation tests were performed on the different formulations immediately after tasting and 2-5 min after the study drug has been spat out.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | L-PZQ Then Rac-PZQ (Day 1) | Subjects were administered L- Praziquantel (L-PZQ) 150 milligram (mg) oral disintegrating tablet (ODT) in first intervention period followed by racemate praziquantel (Rac-PZQ) 150 mg ODT in the second intervention period. A washout period of 1 hour was maintained between the intervention periods. The intervention was directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention (Day 1) |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Rac-PZQ ODT | Drug | Rac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg put and disintegrated in the mouth without water |
|
|
| L-PZQ ODT | Drug | L-PZQ (MSC2499550A) tablet at a dose of 150 mg dispersed in water |
|
|
| Rac-PZQ ODT | Drug | Rac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg dispersed in water |
|
|
| Cesol® | Drug | Cesol® tablet at a dose of 150 mg crushed in water |
|
|
Mouth feeling was described in terms of "sweet", "bitter", "sticky" or "smooth" as per the experience of the subject with the trial medication. |
| 2-5 minutes (After the IMP has been spat out) |
| Number of Subjects With Discomfort or Observations Relating to Acceptance of the Study Medication | 2-5 minutes |
| FG001 | Rac-PZQ Then L-PZQ (Day 1) | Subjects were administered Rac-PZQ 150 mg ODT in first intervention period followed by L-PZQ 150 mg ODT in the second intervention period. A washout period of 1 hour was maintained between the intervention periods. The intervention was directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity. |
| FG002 | L-PZQ Then Rac-PZQ Then Cesol® (Day 2) | Subjects who were randomized to either 'L-PZQ Then Rac-PZQ' or 'Rac-PZQ Then L-PZQ' sequence on Day 1 received L-PZQ 150 mg ODT as a solution via a syringe in the buccal cavity in third intervention period followed by Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in fourth intervention period and then Cesol® (currently available praziquantel tablet) 150 mg administered as a suspension via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity. |
| FG003 | L-PZQ Then Cesol® Then Rac-PZQ (Day 2) | Subjects who were randomized to either 'L-PZQ Then Rac-PZQ' or 'Rac-PZQ Then L-PZQ' sequence on Day 1 received L-PZQ 150 mg ODT as a solution via a syringe in the buccal cavity in third intervention period followed by Cesol® 150 mg administered as a suspension via a syringe in the buccal cavity in fourth intervention period and then Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity. |
| FG004 | Rac-PZQ Then Cesol® Then L-PZQ (Day 2) | Subjects who were randomized to either 'L-PZQ Then Rac-PZQ' or 'Rac-PZQ Then L-PZQ' sequence on Day 1 received Rac-PZQ 150 mg ODT as a solution via a syringe in the buccal cavity in third intervention period followed by Cesol® 150 mg administered as a suspension via a syringe in the buccal cavity in fourth intervention period and then L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity. |
| FG005 | Rac-PZQ Then L-PZQ Then Cesol® (Day 2) | Subjects who were randomized to either 'L-PZQ Then Rac-PZQ' or 'Rac-PZQ Then L-PZQ' sequence on Day 1 received Rac-PZQ 150 mg ODT as a solution via a syringe in the buccal cavity in third intervention period followed by L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in fourth intervention period and then Cesol® 150 mg administered as a suspension via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity. |
| FG006 | Cesol® Then L-PZQ Then Rac-PZQ (Day 2) | Subjects who were randomized to either 'L-PZQ Then Rac-PZQ' or 'Rac-PZQ Then L-PZQ' sequence on Day 1 received Cesol® 150 mg as a suspension via a syringe in the buccal cavity in third intervention period followed by L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in fourth intervention period and then Rac -PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity. |
| FG007 | Cesol® Then Rac-PZQ Then L-PZQ (Day 2) | Subjects who were randomized to either 'L-PZQ Then Rac-PZQ' or 'Rac-PZQ Then L-PZQ' sequence on Day 1 received Cesol® 150 mg as a suspension via a syringe in the buccal cavity in third intervention period followed by Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in fourth intervention period and then L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Second Intervention (Day 1) |
|
| Third Intervention (Day 2) |
|
| Fourth Intervention (Day 2) |
|
| Fifth Intervention (Day 2) |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | L-PZQ Then Rac-PZQ (Day 1) | L- Praziquantel (L-PZQ) 150 milligram (mg) oral disintegrating tablet (ODT) in first intervention period followed by racemate praziquantel (Rac-PZQ) 150 mg ODT in the second intervention period. A washout period of 1 hour was maintained between the intervention periods. The intervention was directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity. |
| BG001 | Rac-PZQ Then L-PZQ (Day 1) | Rac-PZQ 150 mg ODT in first intervention period followed by L-PZQ 150 mg ODT in the second intervention period. A washout period of 1 hour was maintained between the intervention periods. The intervention was directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Gender | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Palatability Visual Analogue Scale (VAS) Score at 0 Minute (Right After the Spit-out of the Investigational Medicinal Product [IMP]) | Overall palatability was assessed on a 0 to 100 unit VAS scale, where higher scores indicate better palatability. | The Safety Set (SAF) included all enrolled subjects who received at least 1 dose of any study drug. | Posted | Mean | Standard Deviation | units on a scale | 0 minute (Right After the Spit-out of the IMP) |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Overall Palatability VAS Score at 2-5 Minutes | Overall palatability was assessed on a 0 to 100 unit VAS scale, where higher scores indicate better palatability. | The Safety Set (SAF) included all enrolled subjects who received at least 1 dose of any study drug. | Posted | Mean | Standard Deviation | units on a scale | 2-5 minutes (After the IMP has been spat out) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Mouth Feeling and Taste Description Evaluation | Mouth feeling was described in terms of "sweet", "bitter", "sticky" or "smooth" as per the experience of the subject with the trial medication. | The data for this outcome measure could not be evaluated as data were not collected according to protocol. | Posted | 2-5 minutes (After the IMP has been spat out) |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Discomfort or Observations Relating to Acceptance of the Study Medication | The Safety Set (SAF) included all enrolled subjects who received at least 1 dose of any study drug. | Posted | Number | Subjects | 2-5 minutes |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | L-PZQ (Without Water) Day 1 | All subjects who received L-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity. | 0 | 48 | 0 | 48 | ||
| EG001 | Rac-PZQ (Without Water) Day 1 | All subjects who received Rac-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity. | 0 | 48 | 1 | 48 | ||
| EG002 | L-PZQ (With Water) Day 2 | All subjects who received L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity. | 0 | 47 | 0 | 47 | ||
| EG003 | Rac-PZQ (With Water) Day 2 | All subjects who received Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity. | 0 | 47 | 0 | 47 | ||
| EG004 | Cesol® (With Water) Day 2 | All subjects who received Cesol® administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles. | 0 | 47 | 0 | 47 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malaria | Infections and infestations | MedDRA | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@merckgroup.com |
| ID | Term |
|---|---|
| D011223 | Praziquantel |
| ID | Term |
|---|---|
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| OG003 | Rac-PZQ (With Water) Day 2 | All subjects who received Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity. |
| OG004 | Cesol® (With Water) Day 2 | All subjects who received Cesol® administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles. |
|
|
| OG003 | Rac-PZQ (With Water) Day 2 | All subjects who received Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity. |
| OG004 | Cesol® (With Water) Day 2 | All subjects who received Cesol® administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles. |
|
| OG003 | Rac-PZQ (With Water) Day 2 | All subjects who received Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity. |
| OG004 | Cesol® (With Water) Day 2 | All subjects who received Cesol® administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles. |
|
|