Trial Outcomes & Findings for 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 NCT02315352)

NCT ID: NCT02315352

Last Updated: 2017-03-06

Results Overview

Overall palatability was assessed on a 0 to 100 unit VAS scale, where higher scores indicate better palatability.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

48 participants

Primary outcome timeframe

0 minute (Right After the Spit-out of the IMP)

Results posted on

2017-03-06

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.	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.	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.	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.	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.
First Intervention (Day 1) STARTED	0	24	24	0	0	0	0	0
First Intervention (Day 1) COMPLETED	0	24	24	0	0	0	0	0
First Intervention (Day 1) NOT COMPLETED	0	0	0	0	0	0	0	0
Second Intervention (Day 1) STARTED	0	24	24	0	0	0	0	0
Second Intervention (Day 1) COMPLETED	0	24	24	0	0	0	0	0
Second Intervention (Day 1) NOT COMPLETED	0	0	0	0	0	0	0	0
Third Intervention (Day 2) STARTED	8	0	0	7	8	8	7	9
Third Intervention (Day 2) COMPLETED	8	0	0	7	8	8	7	9
Third Intervention (Day 2) NOT COMPLETED	0	0	0	0	0	0	0	0
Fourth Intervention (Day 2) STARTED	8	0	0	7	8	8	7	9
Fourth Intervention (Day 2) COMPLETED	8	0	0	7	8	8	7	9
Fourth Intervention (Day 2) NOT COMPLETED	0	0	0	0	0	0	0	0
Fifth Intervention (Day 2) STARTED	8	0	0	7	8	8	7	9
Fifth Intervention (Day 2) COMPLETED	8	0	0	7	8	8	7	9
Fifth Intervention (Day 2) NOT COMPLETED	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	L-PZQ Then Rac-PZQ (Day 1) n=24 Participants 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.	Rac-PZQ Then L-PZQ (Day 1) n=24 Participants 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.	Total n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	24 Participants n=93 Participants	24 Participants n=4 Participants	48 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Gender Female	12 Participants n=93 Participants	12 Participants n=4 Participants	24 Participants n=27 Participants
Gender Male	12 Participants n=93 Participants	12 Participants n=4 Participants	24 Participants n=27 Participants

PRIMARY outcome

Timeframe: 0 minute (Right After the Spit-out of the IMP)

Population: The Safety Set (SAF) included all enrolled subjects who received at least 1 dose of any study drug.

Overall palatability was assessed on a 0 to 100 unit VAS scale, where higher scores indicate better palatability.

Outcome measures

Outcome measures
Measure	L-PZQ (Without Water) Day 1 n=48 Participants 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.	Rac-PZQ (Without Water) Day 1 n=48 Participants 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.	L-PZQ (With Water) Day 2 n=47 Participants 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.	Rac-PZQ (With Water) Day 2 n=47 Participants 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.	Cesol® (With Water) Day 2 n=47 Participants 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.
Overall Palatability Visual Analogue Scale (VAS) Score at 0 Minute (Right After the Spit-out of the Investigational Medicinal Product [IMP])	49.0 units on a scale Standard Deviation 33.65	39.3 units on a scale Standard Deviation 28.43	67.5 units on a scale Standard Deviation 31.14	51.4 units on a scale Standard Deviation 32.35	20.3 units on a scale Standard Deviation 24.91

SECONDARY outcome

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

Population: The Safety Set (SAF) included all enrolled subjects who received at least 1 dose of any study drug.

Overall palatability was assessed on a 0 to 100 unit VAS scale, where higher scores indicate better palatability.

Outcome measures

Outcome measures
Measure	L-PZQ (Without Water) Day 1 n=48 Participants 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.	Rac-PZQ (Without Water) Day 1 n=48 Participants 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.	L-PZQ (With Water) Day 2 n=47 Participants 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.	Rac-PZQ (With Water) Day 2 n=47 Participants 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.	Cesol® (With Water) Day 2 n=47 Participants 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.
Overall Palatability VAS Score at 2-5 Minutes	50.7 units on a scale Standard Deviation 27.23	45.1 units on a scale Standard Deviation 29.62	61.1 units on a scale Standard Deviation 21.19	50.2 units on a scale Standard Deviation 25.92	33.5 units on a scale Standard Deviation 22.23

SECONDARY outcome

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

Population: The data for this outcome measure could not be evaluated as data were not collected according to protocol.

Mouth feeling was described in terms of "sweet", "bitter", "sticky" or "smooth" as per the experience of the subject with the trial medication.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2-5 minutes

Population: The Safety Set (SAF) included all enrolled subjects who received at least 1 dose of any study drug.