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

Study Overview
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Brief Summary
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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 To obtain feedback from children regarding the taste of different formulations using an open ended questionnaire To document any discomfort or other observation in relation to acceptance of the study medication

Detailed Description
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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: L-PZQ ODT (150 mg) put and disintegrated in the mouth Rac- PZQ ODT (150 mg) put and disintegrated in the mouth On Day 2, the subjects will assess the palatability of the following arms in a randomized sequence: L-PZQ ODT (150 mg) dispersed in water administered in the mouth cavity Rac- ODT (150 mg) dispersed in water administered in the mouth cavity 150 mg current PZQ tablet (1/4 of a 600 mg tablet) crushed, dispersed in water and administered in the mouth cavity 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.

Official Title
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Randomized, Single Blind, Cross-over Study to Evaluate the Palatability of New Orally Disintegrating Tablets of PZQ and L-PZQ Versus Current PZQ Tablets in African Children Age 6-11 Years

Conditions
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Healthy

Intervention / Treatment
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* Drug: L-PZQ ODT
* Drug: Rac-PZQ ODT
* Drug: L-PZQ ODT
* Drug: Rac-PZQ ODT
* Drug: Cesol®


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Children male or female aged 6-11 years (inclusive) Parents or guardians gave written informed consent prior to any trial related procedure and child gave assent Able to communicate well with the Investigator, understanding the protocol requirements and restrictions, and willing to comply with the requirements of the entire trial Subjects should be able to hold 2 milliliter (mL) of any appropriate juice in their mouth for 10 seconds without swallowing it and to keep a candy in the mouth for 20 seconds without swallowing it Children who are able to properly assess and differentiate flavours of different soft drinks Children who are able to use a hedonic scale (children were trained before the study) Exclusion criteria: Unlikely to comply with the protocol requirements, instructions and trial-related restrictions, example: uncooperative attitude, inability to return for follow-up visits, and improbability of completing the trial Children with any condition or dietary habit known to interfere with the sense of smell and taste, ingestion of any medication (except paracetamol) Children with significant illness in the previous 2 weeks Any surgical or medical condition, or any significant disease that in the opinion of the investigator, constitutes a risk or a contraindication for the participation of the subject in the study that could interfere with the study objectives, conduct or evaluation Children who have participated in any clinical investigation within the previous 4 weeks

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Period 1 and 2<br>A-B or B-A where A: L-PZQ ODT (MSC 2499550A) put on tongue; B: Rac-PZQ ODT (MSC1028703A) put on the tongue | Drug: L-PZQ ODT<br>* L-PZQ ODT (MSC2499550A) tablet at a dose of 150 milligram (mg) put and disintegrated in the mouth without water<br>* Other names: MSC 2499550A;Drug: Rac-PZQ ODT<br>* Rac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg put and disintegrated in the mouth without water<br>* Other names: MSC1028703;|
| Experimental: Period 3, 4 and 5<br>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 | Drug: L-PZQ ODT<br>* L-PZQ (MSC2499550A) tablet at a dose of 150 mg dispersed in water<br>* Other names: MSC 2499550A;Drug: Rac-PZQ ODT<br>* Rac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg dispersed in water<br>* Other names: MSC1028703A;Drug: Cesol®<br>* Cesol® tablet at a dose of 150 mg crushed in water<br>* Other names: PZQ;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy, L-PZQ, PZQ, MSC2499550A, Praziquantel