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 | Completed Phase 1 Results

• 1 other identifier: EMR200661-002
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

Healthy; L-PZQ; PZQ; MSC2499550A; Praziquantel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall Palatability VAS Score at 2-5 Minutes

  2-5 minutes (After the IMP has been spat out)

• Number of Subjects With Mouth Feeling and Taste Description Evaluation

  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

Study Arms (2)

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

Drug: L-PZQ ODT; Drug: Rac-PZQ ODT

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

Drug: L-PZQ ODT; Drug: Rac-PZQ ODT; Drug: Cesol®

Interventions

L-PZQ ODT DRUG

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

Also known as: MSC 2499550A

Period 1 and 2

Rac-PZQ ODT DRUG

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

Also known as: MSC1028703

Period 1 and 2

Cesol® DRUG

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

Also known as: PZQ

Period 3, 4 and 5

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Swiss Tropical & Public Health Institute: collaborator

Study Sites (1)

Ifakara Health Institute

Ikwiriri, Rufiji, Tanzania

Location

Related Publications (2)

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

  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.

  PMID: 34106922 DERIVED

MeSH Terms

Interventions

Praziquantel

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 11, 2014
• Study Start: April 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: March 6, 2017
• Results First Posted: March 6, 2017

Record last verified: 2017-01

Locations

TA (1)