Last updated: 11/04/2018 08:11:04
Evaluation Of Valaciclovir In Patients With Chickenpox
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Clinical Evaluation of Valaciclovir Hydrochloride: 256U87 in Patients with Chickenpox - Open Uncontrolled Study.
Trial description: This study will assess the safety and efficacy, and the pharmacokinetics of aciclovir and valaciclovir in children with chickenpox following oral administration of valaciclovir, for the purpose of seeking approval of valaciclovir HCl for the treatment of chickenpox.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: valaciclovir HCl granules
Enrollment:
43
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Varicella
Product
valaciclovir
Collaborators
Not applicable
Study date(s)
March 2005 to August 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
1 - 11 years
Accepts healthy volunteers
No
- Subjects aged 1 year to less than 12 years with a clinical diagnosis of chickenpox within 48 hours of the onset of the rash.
- History of hypersensitivity reactions.
- Impaired hepatic or renal function.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects aged 1 year to less than 12 years with a clinical diagnosis of chickenpox within 48 hours of the onset of the rash.
Exclusion criteria:
- History of hypersensitivity reactions.
- Impaired hepatic or renal function.
- Gastrointestinal dysfunction.
- Serious underlying disease.
- Weigh over 40kg.
- Vaccinated for chickenpox.
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-02-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website