Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)

NCT01390857 | Completed Results

• 1 other identifier: 112323
• Study Type: observational
• Target: 379
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this post-marketing surveillance study is to collect and assess information on safety and efficacy of valaciclovir in pediatric patients with chickenpox

Conditions

Varicella

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Any Serious Adverse Event

  A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, please see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record.

  1 month

Secondary Outcomes (3)

• Number of Participants With the Indicated Adverse Drug Reactions

  1 month

• Number of Participants With Any Unexpected Adverse Drug Reactions

  1 month

• Number of Participants Classified as Effective and Not Effective

  1 month

Study Arms (1)

Pediatric patients prescribed valaciclovir

Pediatric patients with chickenpox prescribed valaciclovir during study period.

Drug: Valaciclovir

Interventions

Valaciclovir DRUG

Pediatric patients prescribed valaciclovir

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Japanese pediatric patients with chickenpox (aged less than 15 years old)

You may qualify if:

• Pediatric patients with chickenpox (aged less than 15 years old).

You may not qualify if:

• Patients with a history of hypersensitivity to the ingredients of valaciclovir or acyclovir.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Chickenpox

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 11, 2011
• Study Start: November 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: May 1, 2010
• Last Updated: May 17, 2017
• Results First Posted: September 26, 2011

Record last verified: 2017-05