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 ID: NCT02315352

Last Updated: 2017-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-05-31

Brief Summary

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

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Period 1 and 2

A-B or B-A where A: L-PZQ ODT (MSC 2499550A) put on tongue; B: Rac-PZQ ODT (MSC1028703A) put on the tongue

Group Type: EXPERIMENTAL

L-PZQ ODT

Intervention Type: DRUG

L-PZQ ODT (MSC2499550A) tablet at a dose of 150 milligram (mg) put and disintegrated in the mouth without water

Rac-PZQ ODT

Intervention Type: DRUG

Rac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg put and disintegrated in the mouth without water

Period 3, 4 and 5

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

Group Type: EXPERIMENTAL

L-PZQ ODT

Intervention Type: DRUG

L-PZQ (MSC2499550A) tablet at a dose of 150 mg dispersed in water

Rac-PZQ ODT

Intervention Type: DRUG

Rac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg dispersed in water

Cesol®

Intervention Type: DRUG

Cesol® tablet at a dose of 150 mg crushed in water

Interventions

L-PZQ ODT

L-PZQ ODT (MSC2499550A) tablet at a dose of 150 milligram (mg) put and disintegrated in the mouth without water

Intervention Type: DRUG

Rac-PZQ ODT

Rac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg put and disintegrated in the mouth without water

Intervention Type: DRUG

L-PZQ ODT

L-PZQ (MSC2499550A) tablet at a dose of 150 mg dispersed in water

Intervention Type: DRUG

Rac-PZQ ODT

Rac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg dispersed in water

Intervention Type: DRUG

Cesol®

Cesol® tablet at a dose of 150 mg crushed in water

Intervention Type: DRUG

Other Intervention Names

MSC 2499550A; MSC1028703; MSC 2499550A; MSC1028703A; PZQ

Eligibility Criteria

Inclusion Criteria

1. Children male or female aged 6-11 years (inclusive)

2. Parents or guardians gave written informed consent prior to any trial related procedure and child gave assent

3. Able to communicate well with the Investigator, understanding the protocol requirements and restrictions, and willing to comply with the requirements of the entire trial

4. 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

5. Children who are able to properly assess and differentiate flavours of different soft drinks

6. Children who are able to use a hedonic scale (children were trained before the study)

Exclusion Criteria

1. 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

2. Children with any condition or dietary habit known to interfere with the sense of smell and taste, ingestion of any medication (except paracetamol)

3. Children with significant illness in the previous 2 weeks

4. 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

5. Children who have participated in any clinical investigation within the previous 4 weeks

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Swiss Tropical & Public Health Institute

OTHER

Sponsor Role: collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Merck KGaA, Darmstadt, Germany

Locations

Ifakara Health Institute

Ikwiriri, Rufiji, Tanzania

Countries

Tanzania

References

CHMP. (2005). Reflection paper: formulation of choice for the paediatric population. EMA

Reference Type: BACKGROUND

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.

Reference Type: DERIVED

PMID: 34106922 (View on PubMed)

Other Identifiers

EMR200661-002

Identifier Type: -

Identifier Source: org_study_id