Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201412000959159 Date of Approval: 03/12/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Praziquantel taste assessment study
Official scientific 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
Brief summary describing the background and objectives of the trial 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. Enrolments 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. 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. 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". 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).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PZQ taste study
Disease(s) or condition(s) being studied Infections and Infestations,Schistosomiasis
Sub-Disease(s) or condition(s) being studied Schistosomiasis
Purpose of the trial Treatment: Other
Anticipated trial start date 02/02/2015
Actual trial start date 25/04/2015
Anticipated date of last follow up 07/03/2015
Actual Last follow-up date 31/05/2015
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
EMR200661-002 Merck KGaA
NCT Number Pending Clinicaltrial.gov
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised stratified allocation by gender and agegroup Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group L-PZQ ODT (MSC 2499550A) put on tongue 150 mg once Tablet put and disintegrated in the mouth without water 48
Experimental Group Rac-PZQ ODT (MSC1028703A) put on the tongue 150 mg once Tablet put and disintegrated in the mouth without water 48
Experimental Group L-PZQ ODT (MSC 2499550A) dispersed in water 150 mg once tablet at a dose of 150 mg is dispersed in water 48
Experimental Group Rac-PZQ ODT (MSC1028703A) dispersed in water 150 mg once Tablet at a dose of 150 mg is dispersed in water 48
Control Group Cesol® crushed in water 150 mg once Cesol® tablet at a dose of 150 mg crushed in water 48 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 will be trained before the study) 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 6 Year(s) 11 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/10/2014 Ifakara Health Institute-IRB
Ethics Committee Address
Street address City Postal code Country
P.O. Box 9653 Dar Es Salaam Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 20/10/2014 National Institute for Medical Research (NIMR)
Ethics Committee Address
Street address City Postal code Country
2448, Luthuli /Ocean Road Dar Es Salaam P.O. Box 9653 Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 21/11/2014 Ethics Committee Northwestern/Central Switzerland
Ethics Committee Address
Street address City Postal code Country
Hebelstr. 53 Basel 4056 Switzerland
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Overall palatability will be assessed by putting a mark along the 0-100 millimeter VAS that incorporates a 5-point hedonic scale directly after spitting
Secondary Outcome Overall palatability will be assessed by putting a mark along the 0-100 millimeter VAS that incorporates a 5-point hedonic scale and answering the questionnaire that contains "very poor taste", "poor taste", "neither good nor bad", "good taste" and "very good taste" where higher score indicates good taste. 2-5 min post spitting
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
IHI site Ikwiriri Ikwiriri Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Merck KGaA Frankfurter Strasse 250 Darmstadt 64293 Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Merck KGaA Frankfurter Strasse 250 Darmstadt 64293 Germany Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Deon Bezuidenhout 1 Friesland Drive, Longmeadow Business Estate Modderfontein 1645 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdunoor Mulokozi Kabanywanyi amulokozi@ihi.or.tz +255 783 126 585 Kiko Ave, Mikocheni
City Postal code Country Position/Affiliation
Dar Es Salaam P O Box 78373 Tanzania Principal Investigator
Role Name Email Phone Street address
Public Enquiries Eric Huber eric.huber@unibas.ch +41 61 284 89 72 Soncinstr. 57
City Postal code Country Position/Affiliation
Basel P.O. Box 4002 Switzerland Swiss TPH Project leader
Role Name Email Phone Street address
Scientific Enquiries Wilhelmina Bagchus wilhelmina.bagchus@emdserono.com +1 978-294-1231 45A Middlesex Turnpike
City Postal code Country Position/Affiliation
Basel Billerica, MA United States of America EMD Serono R&D Institute Protocol Lead
REPORTING
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Changes to trial information