Trial Outcomes & Findings for Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox) (NCT NCT01390857)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

379 participants

Primary outcome timeframe

1 month

Results posted on

2017-05-17

Participant Flow

This post-marketing surveillance (PMS) study was designed to evaluate the safety and efficacy of valaciclovir in pediatric participants with chickenpox.

Participant milestones

Participant milestones
Measure	Valaciclovir VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
Overall Study STARTED	379
Overall Study COMPLETED	369
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Valaciclovir VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
Overall Study Protocol Violation	2
Overall Study Lost to Follow-up	1
Overall Study No Visit after the First Visit	7

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Valaciclovir n=369 Participants VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
Age, Customized >=1 month to <1 year	16 Participants n=5 Participants
Age, Customized >=1 to <7 years	311 Participants n=5 Participants
Age, Customized >=7 to <=13 years	42 Participants n=5 Participants
Sex: Female, Male Female	156 Participants n=5 Participants
Sex: Female, Male Male	213 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	369 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: Intent-to-Treat Safety Population: all participants to whom the drug was administered, excluding 10 withdrawal participants.

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.

Outcome measures

Outcome measures
Measure	Valaciclovir n=369 Participants VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
Number of Participants With Any Serious Adverse Event	0 participants

SECONDARY outcome

Timeframe: 1 month

Population: ITT Safety Population

An adverse drug reaction (ADR) is an adverse event whose causal relationship to study drug was not ruled out by the reporting physician. An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all ADRs occurring during the course of the study, please also see the table entitled "Other (non-serious) adverse events" in the Adverse Event section of the results record.

Outcome measures

Outcome measures
Measure	Valaciclovir n=369 Participants VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
Number of Participants With the Indicated Adverse Drug Reactions Urticaria	2 participants
Number of Participants With the Indicated Adverse Drug Reactions Diarrhoea	1 participants

SECONDARY outcome

Timeframe: 1 month

Population: ITT Safety Population

An unexpected adverse drug reaction is an adverse event whose casual relationship to the study drug is not ruled out by the reporting physician and also is not listed in a package insert of the drug.

Outcome measures

Outcome measures
Measure	Valaciclovir n=369 Participants VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
Number of Participants With Any Unexpected Adverse Drug Reactions	0 participants

SECONDARY outcome

Timeframe: 1 month

Population: Efficacy Analysis Set: all participants assessed for efficacy who completed all study visits; 7 participants did not undergo an efficacy evaluation, and 13 participants failed to visit after the first visit.

The course of symptoms was comprehensively assessed by the investigator on a four-category scale (Improved, Unchanged, Worsen, and Unassessable) before and after the initiation of valaciclovir therapy. "Improved" was regarded as "Effective," and "Unchanged" and " Worsen" were regarded as "Not effective." The two participants classifed as "Not effective" were classified as "Unchanged."

Outcome measures

Outcome measures
Measure	Valaciclovir n=349 Participants VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
Number of Participants Classified as Effective and Not Effective Effective	347 participants
Number of Participants Classified as Effective and Not Effective Not effective	2 participants

Adverse Events

Valaciclovir

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Valaciclovir n=369 participants at risk VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
Skin and subcutaneous tissue disorders Urticaria	0.81% 3/369
Gastrointestinal disorders Diarrhoea	0.27% 1/369
Infections and infestations Nasopharyngitis	0.27% 1/369
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.27% 1/369
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.27% 1/369
Skin and subcutaneous tissue disorders Pruritis	0.27% 1/369

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER