HealthyPhase 1NCT02315352

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

A Phase 1 study testing L-PZQ ODT, Rac-PZQ ODT and Cesol® in people with Healthy, run by Merck KGaA, Darmstadt, Germany at 1 site in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 6 to 11 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: L-PZQ ODT, Rac-PZQ ODT and Cesol®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteTanzania
Study dates: Apr 2015to May 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 11 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Tanzania1 site

Ifakara Health Institute
Ikwiriri, Rufiji

Other trials in Tanzania

About this study

Official title: 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

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

Read the 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
Being tested: L-PZQ ODT, Rac-PZQ ODT, Cesol®
Keywords: Healthy, L-PZQ, PZQ, MSC2499550A, Praziquantel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

L-PZQ ODTDrug
Also called MSC 2499550A
L-PZQ ODT (MSC2499550A) tablet at a dose of 150 milligram (mg) put and disintegrated in the mouth without water
Rac-PZQ ODTDrug
Also called MSC1028703
Rac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg put and disintegrated in the mouth without water
L-PZQ ODTDrug
Also called MSC 2499550A
L-PZQ (MSC2499550A) tablet at a dose of 150 mg dispersed in water
Rac-PZQ ODTDrug
Also called MSC1028703A
Rac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg dispersed in water
Cesol®Drug
Also called PZQ
Cesol® tablet at a dose of 150 mg crushed in water

Study groups in NCT02315352
Study group	Role	What they receive
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 Receives: 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 Receives: Drug: L-PZQ ODT; Drug: Rac-PZQ ODT; Drug: Cesol®

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

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.
Measured: 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.
Measured: 2-5 minutes (After the IMP has been spat out)
Number of Subjects With Discomfort or Observations Relating to Acceptance of the Study Medication
Measured: 2-5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2015May 2015

First posted11 Dec 2014 (estimated)
Study startApr 2015
Primary completionMay 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02315352
Sponsor's protocol ID: EMR200661-002
Status last verified: Jan 2017
First submitted: 9 Dec 2014
Last updated: 6 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

CHMP. (2005). Reflection paper: formulation of choice for the paediatric population. EMA
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.
PubMed 34106922

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02315352
Acronym / sponsor ID: EMR200661-002
Conditions: Healthy
Keywords: Healthy, L-PZQ, PZQ, MSC2499550A, Praziquantel
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
Collaborators: Swiss Tropical & Public Health Institute
Study start: Apr 2015
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 11 Dec 2014 (estimated)
Results: Posted 6 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

-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.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Period 1 and 2	Experimental	Drug: L-PZQ ODT, Drug: Rac-PZQ ODTA-B or B-A where A: L-PZQ ODT (MSC 2499550A) put on tongue; B: Rac-PZQ ODT (MSC1028703A) put on the tongue
Period 3, 4 and 5	Experimental	Drug: L-PZQ ODT, Drug: Rac-PZQ ODT, Drug: Cesol®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

Who may qualify

Ages: 6 to 11 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
L-PZQ ODTAlso: MSC 2499550AL-PZQ ODT (MSC2499550A) tablet at a dose of 150 milligram (mg) put and disintegrated in the mouth without water	Drug	Period 1 and 2
Rac-PZQ ODTAlso: MSC1028703Rac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg put and disintegrated in the mouth without water	Drug	Period 1 and 2
L-PZQ ODTAlso: MSC 2499550AL-PZQ (MSC2499550A) tablet at a dose of 150 mg dispersed in water	Drug	Period 3, 4 and 5
Rac-PZQ ODTAlso: MSC1028703ARac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg dispersed in water	Drug	Period 3, 4 and 5
Cesol®Also: PZQCesol® tablet at a dose of 150 mg crushed in water	Drug	Period 3, 4 and 5

Primary outcome

Overall Palatability Visual Analogue Scale (VAS) Score at 0 Minute (Right After the Spit-out of the Investigational Medicinal Product [IMP])
Time frame: 0 minute (Right After the Spit-out of the IMP)
Overall palatability was assessed on a 0 to 100 unit VAS scale, where higher scores indicate better palatability.

3 secondary outcomes

Overall Palatability VAS Score at 2-5 Minutes
Time frame: 2-5 minutes (After the IMP has been spat out)
Number of Subjects With Mouth Feeling and Taste Description Evaluation
Time frame: 2-5 minutes (After the IMP has been spat out)
Number of Subjects With Discomfort or Observations Relating to Acceptance of the Study Medication
Time frame: 2-5 minutes

Results and safety

Results posted to the registry on 6 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
L-PZQ Then Rac-PZQ (Day 1)	24	24
Rac-PZQ Then L-PZQ (Day 1)	24	24
L-PZQ Then Rac-PZQ Then Cesol® (Day 2)	0	0
L-PZQ Then Cesol® Then Rac-PZQ (Day 2)	0	0
Rac-PZQ Then Cesol® Then L-PZQ (Day 2)	0	0
Rac-PZQ Then L-PZQ Then Cesol® (Day 2)	0	0
Cesol® Then L-PZQ Then Rac-PZQ (Day 2)	0	0
Cesol® Then Rac-PZQ Then L-PZQ (Day 2)	0	0

Primary outcome: Overall Palatability Visual Analogue Scale (VAS) Score at 0 Minute (Right After the Spit-out of the Investigational Medicinal Product [IMP])

Time frame: 0 minute (Right After the Spit-out of the IMP). Mean (Standard Deviation). Unit: units on a scale

Measure	L-PZQ (Without Water) Day 1 n = 48	Rac-PZQ (Without Water) Day 1 n = 48	L-PZQ (With Water) Day 2 n = 47	Rac-PZQ (With Water) Day 2 n = 47	Cesol® (With Water) Day 2 n = 47
Value	49.0 (33.65)	39.3 (28.43)	67.5 (31.14)	51.4 (32.35)	20.3 (24.91)

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

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
L-PZQ (Without Water) Day 1	0 of 48 (0%)	0 of 48 (0%)	Not reported
Rac-PZQ (Without Water) Day 1	0 of 48 (0%)	1 of 48 (2.1%)	Not reported
L-PZQ (With Water) Day 2	0 of 47 (0%)	0 of 47 (0%)	Not reported
Rac-PZQ (With Water) Day 2	0 of 47 (0%)	0 of 47 (0%)	Not reported
Cesol® (With Water) Day 2	0 of 47 (0%)	0 of 47 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundCHMP. (2005). Reflection paper: formulation of choice for the paediatric population. EMA
Derived from this study: PubMed 34106922Mahende 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Responsible study director

Merck KGaA, Darmstadt, Germany

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing L-PZQ ODT, Rac-PZQ ODT and Cesol® in people with Healthy, run by Merck KGaA, Darmstadt, Germany at 1 site in Tanzania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Palatability Visual Analogue Scale (VAS) Score at 0 Minute (Right After the Spit-out of the Investigational Medicinal Product [IMP]) (time frame: 0 minute (Right After the Spit-out of the IMP)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02315352, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.