Palatability Testing of a New Paediatric Formulation of Valacyclovir - VALID 0 (VALID0)
This study is currently recruiting participants.
Verified November 2012 by Radboud University
Sponsor:
Radboud University
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01682109
First received: September 5, 2012
Last updated: November 12, 2012
Last verified: November 2012
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Purpose
Palatability testing of 3 different formulations of a newly developed paediatric valacyclovir oral solution in children 4-12 years of age and at least one of their parents. Children will be included, who received (val)acyclovir prophylaxis in the past, or will probably need it in the future i.e. children with primary immune deficiency or cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Varicella Zoster Virus Infection Herpes Simplex Virus Infection |
Drug: Valacyclovir |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) |
| Official Title: | Palatability Testing of a New Paediatric Formulation of Valacyclovir for the Prophylaxis and Treatment of VZV and HSV Infections in Children - VALID 0 |
Resource links provided by NLM:
Further study details as provided by Radboud University:
Primary Outcome Measures:
- Selection of oral solution with best taste [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Patients (children) will assess the taste of 3 different oral solutions. A questionnaire has to be completed to order the palatability of the three formulations.
Secondary Outcome Measures:
- Taste assessment [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Children will score the taste of 3 different oral valacyclovir solutions. A 100 mm facial hedonic scale will be employed to indicate the palatability of each formulation.
- Predictability of palatability preference of the child by parents. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]To determine whether parents can predict the palatability preference of their child.
| Estimated Enrollment: | 70 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Raspberry
Raspberry taste valacyclovir solution
|
Drug: Valacyclovir
Children of 4-8 years will taste 2 ml of each solution and children of 8-12 years and the parent(s) will taste 4 ml of each solution.
Other Name: 50 mg/ml valacyclovir solution
|
|
Experimental: Orange
Orange taste valacyclovir solution
|
Drug: Valacyclovir
Children of 4-8 years will taste 2 ml of each solution and children of 8-12 years and the parent(s) will taste 4 ml of each solution.
Other Name: 50 mg/ml valacyclovir solution
|
|
Active Comparator: Plain
Plain valacyclovir solution
|
Drug: Valacyclovir
Children of 4-8 years will taste 2 ml of each solution and children of 8-12 years and the parent(s) will taste 4 ml of each solution.
Other Name: 50 mg/ml valacyclovir solution
|
Eligibility| Ages Eligible for Study: | 4 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Subject is at least 4 years of age.
- Subject weighs at least 15kg.
- Subject is capable of performing the taste assessment, according to the investigator's judgement.
- The child and parent(s) are willing to participate in the taste assessment.
- Signed informed consent by the legal guardian for participation of the child and if the parent also wants to participate: signed informed consent for their own participation, prior to start of the study.
Exclusion Criteria:
- Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
- Presence of any condition that influences taste sensation (such as upper respiratory infection, febrile illness within 3 days before the first dose, mucositis or use of medication that influences taste perception, as described in the label information).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682109
Contacts
| Contact: David Burger, PharmD, PhD | +31243616405 | d.burger@akf.umcn.nl |
| Contact: Diane Bastiaans | +31243616405 | D.Bastiaans@akf.umcn.nl |
Locations
| Netherlands | |
| Radboud University Nijmegen Medical Centre | Recruiting |
| Nijmegen, Netherlands | |
| Contact: Diane Bastiaans +31243616405 D.Bastiaans@akf.umcn.nl | |
| Contact: Angela Colbers +31243616405 A.Colbers@akf.umcn.nl | |
| Principal Investigator: Adilia Warris, MD | |
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
| Principal Investigator: | Adilia Warris, MD | Radboud University |
More Information
No publications provided
| Responsible Party: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT01682109 History of Changes |
| Other Study ID Numbers: | UMCN-AKF 11.05 |
| Study First Received: | September 5, 2012 |
| Last Updated: | November 12, 2012 |
| Health Authority: | Netherlands: Ministry of Health, Welfare and Sport |
Keywords provided by Radboud University:
|
prophylaxis herpes zoster herpes simplex |
valacyclovir palatability paediatric |
Additional relevant MeSH terms:
|
Chickenpox Herpes Zoster Herpes Simplex Virus Diseases Herpesviridae Infections DNA Virus Infections Skin Diseases, Viral Skin Diseases, Infectious |
Skin Diseases Valacyclovir Acyclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013