Phase 1
Completed N=48
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
Healthy
Source: ClinicalTrials.gov NCT02315352 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Overall Palatability Visual Analogue Scale (VAS) Score at 0 Minute (Right After the Spit-out of the Investigational Medicinal Product [IMP]) — 49.0; 39.3; 67.5; 51.4 units on a scale
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Palatability Visual Analogue Scale (VAS) Score at 0 Minute (Right After the Spit-out of the Investigational Medicinal Product [IMP]) |
49.0; 39.3; 67.5; 51.4; 20.3 | — |
| SECONDARY Overall Palatability VAS Score at 2-5 Minutes |
50.7; 45.1; 61.1; 50.2; 33.5 | — |
| SECONDARY Number of Subjects With Mouth Feeling and Taste Description Evaluation |
— | — |
| SECONDARY Number of Subjects With Discomfort or Observations Relating to Acceptance of the Study Medication |
0; 0; 2; 0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02315352). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.