Trial · NCT00098059

Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection

NCT00098059, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2009-05-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection. Trials, record NCT00098059. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00098059

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection
NCT number: NCT00098059
Status: Completed
Phases: Phase 3
Enrollment: 74 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Herpes Simplex
Interventions: Famciclovir
First posted: 2004-12-03
Last updated: 2013-04-25
Results first posted: 2009-05-06

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.	8 hours and 24 hours after study drug administration (Part A)	A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row.
Primary	Maximum Observed Plasma Concentration of Penciclovir (Cmax)	plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose	PK parameter; penciclovir is the active metabolite of famciclovir.
Primary	Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax)	Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose	PK parameter; penciclovir is the active metabolite of famciclovir.
Primary	Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)	Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose	PK parameter; penciclovir is the active metabolite of famciclovir.
Primary	Apparent Oral Clearance of Penciclovir (CL/F)	Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose	PK parameter; penciclovir is the active metabolite of famciclovir.
Primary	Apparent Terminal Elimination Half-life of Penciclovir (T1/2)	Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose	PK parameter; penciclovir is the active metabolite of famciclovir
Primary	Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.	Administered 2 times daily over 7 days	A patient with multiple AEs within the primary system organ class is counted only once in total row.
Secondary	Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.	Day 1, after swallowing the dose.	Overall acceptability of the study medication was determined by caretaker response.
Secondary	Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study.	Day 1 at clinic: after swallowing first dose	Overall acceptability of the study medication was determined by caretaker response.
Secondary	Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study	Day 8 at home: after swallowing last dose	Overall acceptability of study medication was determined by caretaker response.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.	Day 1, after swallowing the dose.	Includes all 27 patients enrolled in Part A of the study.	participants	NUMBER
SECONDARY	Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study.	Day 1 at clinic: after swallowing first dose	Includes all 47 patients enrolled in Part B of the study.	participants	NUMBER
SECONDARY	Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study	Day 8 at home: after swallowing last dose	Includes all 47 patients enrolled in Part B of the study. Response was not available for 1 patient in the 2 to \<6 years and 6 to \<=12 years groups.	participants	NUMBER
PRIMARY	Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.	8 hours and 24 hours after study drug administration (Part A)	Includes all 27 patients enrolled in Part A of the study.	participants	NUMBER
PRIMARY	Maximum Observed Plasma Concentration of Penciclovir (Cmax)	plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose	Includes all 27 patients enrolled in Part A of the study.	μg/mL	MEAN
PRIMARY	Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax)	Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose	Includes all 27 patients enrolled in Part A of the study.	hours	MEDIAN
PRIMARY	Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)	Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose	Includes 26 of 27 patients enrolled in Part A of the study.	(μg/mL)h	MEAN
PRIMARY	Apparent Oral Clearance of Penciclovir (CL/F)	Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose	Includes 26 of 27 patients enrolled in Part A of the study.	L/h	MEAN
PRIMARY	Apparent Terminal Elimination Half-life of Penciclovir (T1/2)	Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose	Includes 26 of 27 patients enrolled in Part A of the study.	hours	MEAN
PRIMARY	Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.	Administered 2 times daily over 7 days	Includes 47 patients enrolled in Part B of the study.	participants	NUMBER

Source ClinicalTrials.gov

Results by group107

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.	1 to < 2 Years	Badly	1	participants
Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.	2 to <6 Years	Badly	4	participants
Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.	6 to <13 Years	Badly	0	participants
Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.	13 to <=18 Years	Badly	2	participants
Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.	1 to < 2 Years	Neither bad nor good	1	participants
Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.	2 to <6 Years	Neither bad nor good	1	participants
Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.	6 to <13 Years	Neither bad nor good	4	participants
Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.	13 to <=18 Years	Neither bad nor good	0	participants
Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.	1 to < 2 Years	Well	2	participants
Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.	2 to <6 Years	Well	8	participants

1 to 10 of 107Source ClinicalTrials.gov

See all 107 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Part A (Single-dose of Famciclovir)	27
Overall Study	STARTED	Part B (Multiple-dose of Famciclovir)	47
Overall Study	COMPLETED	Part A (Single-dose of Famciclovir)	27
Overall Study	COMPLETED	Part B (Multiple-dose of Famciclovir)	46
Overall Study	NOT COMPLETED	Part A (Single-dose of Famciclovir)	0
Overall Study	NOT COMPLETED	Part B (Multiple-dose of Famciclovir)	1

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain upper	Gastrointestinal disorders	Part A (Single-dose of Famciclovir)	2	27
other	Abdominal pain upper	Gastrointestinal disorders	Part B (Multiple-dose of Famciclovir)	2	47
other	Dizziness	Nervous system disorders	Part A (Single-dose of Famciclovir)	1	27
other	Dizziness	Nervous system disorders	Part B (Multiple-dose of Famciclovir)	0	47
other	Headache	Nervous system disorders	Part A (Single-dose of Famciclovir)	2	27
other	Headache	Nervous system disorders	Part B (Multiple-dose of Famciclovir)	4	47
other	Pyrexia	General disorders	Part A (Single-dose of Famciclovir)	1	27
other	Pyrexia	General disorders	Part B (Multiple-dose of Famciclovir)	2	47
other	Furuncle	Infections and infestations	Part A (Single-dose of Famciclovir)	1	27
other	Furuncle	Infections and infestations	Part B (Multiple-dose of Famciclovir)	0	47

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Part A (Single-dose of Famciclovir)
Total, all-cause mortality	Part B (Multiple-dose of Famciclovir)
Total, other adverse events	Part A (Single-dose of Famciclovir)	5	27
Total, other adverse events	Part B (Multiple-dose of Famciclovir)	23	47
Total, serious adverse events	Part A (Single-dose of Famciclovir)	0	27
Total, serious adverse events	Part B (Multiple-dose of Famciclovir)	0	47

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
19273678	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Part A (Single-dose of Famciclovir) vs Part B (Multiple-dose of Famciclovir): serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00098059

GET https://conductscience.org/api/trials/v1/NCT00098059/results?page=2

API reference For AI assistants