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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

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ClinicalTrials.gov Identifier: NCT02315352
Recruitment Status : Completed
First Posted : December 11, 2014
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Collaborator:
Swiss Tropical & Public Health Institute
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

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

Condition or disease Intervention/treatment Phase
Healthy Drug: L-PZQ ODT Drug: Rac-PZQ ODT Drug: Cesol® Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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
Study Start Date : April 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: L-PZQ ODT
L-PZQ ODT (MSC2499550A) tablet at a dose of 150 milligram (mg) put and disintegrated in the mouth without water
Other Name: MSC 2499550A

Drug: Rac-PZQ ODT
Rac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg put and disintegrated in the mouth without water
Other Name: MSC1028703

Experimental: 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
Drug: L-PZQ ODT
L-PZQ (MSC2499550A) tablet at a dose of 150 mg dispersed in water
Other Name: MSC 2499550A

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

Drug: Cesol®
Cesol® tablet at a dose of 150 mg crushed in water
Other Name: PZQ




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall Palatability VAS Score at 2-5 Minutes [ Time Frame: 2-5 minutes (After the IMP has been spat out) ]
    Overall palatability was assessed on a 0 to 100 unit VAS scale, where higher scores indicate better palatability.

  2. Number of Subjects With Mouth Feeling and Taste Description Evaluation [ Time Frame: 2-5 minutes (After the IMP has been spat out) ]
    Mouth feeling was described in terms of "sweet", "bitter", "sticky" or "smooth" as per the experience of the subject with the trial medication.

  3. Number of Subjects With Discomfort or Observations Relating to Acceptance of the Study Medication [ Time Frame: 2-5 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315352


Locations
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Tanzania
Ifakara Health Institute
Ikwiriri, Rufiji, Tanzania
Sponsors and Collaborators
Merck KGaA, Darmstadt, Germany
Swiss Tropical & Public Health Institute
Investigators
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Study Director: Medical Responsible Merck KGaA, Darmstadt, Germany

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

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Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT02315352     History of Changes
Other Study ID Numbers: EMR200661-002
First Posted: December 11, 2014    Key Record Dates
Results First Posted: March 6, 2017
Last Update Posted: March 6, 2017
Last Verified: January 2017

Keywords provided by Merck KGaA, Darmstadt, Germany:
Healthy
L-PZQ
PZQ
MSC2499550A
Praziquantel

Additional relevant MeSH terms:
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Praziquantel
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents