Trial · NCT01390857
Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)
NCT01390857, Completed, GlaxoSmithKline; results first posted 2011-09-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox). Trials, record NCT01390857. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01390857
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)
- NCT number
- NCT01390857
- Status
- Completed
- Enrollment
- 379 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Varicella
- Interventions
- Valaciclovir
- First posted
- 2011-07-11
- Last updated
- 2017-05-17
- Results first posted
- 2011-09-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Any Serious Adverse Event | 1 month | 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. |
| Secondary | Number of Participants With the Indicated Adverse Drug Reactions | 1 month | 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. |
| Secondary | Number of Participants With Any Unexpected Adverse Drug Reactions | 1 month | 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. |
| Secondary | Number of Participants Classified as Effective and Not Effective | 1 month | 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." |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Any Serious Adverse Event | 1 month | Intent-to-Treat Safety Population: all participants to whom the drug was administered, excluding 10 withdrawal participants. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Adverse Drug Reactions | 1 month | ITT Safety Population | participants | NUMBER |
| SECONDARY | Number of Participants With Any Unexpected Adverse Drug Reactions | 1 month | ITT Safety Population | participants | NUMBER |
| SECONDARY | Number of Participants Classified as Effective and Not Effective | 1 month | 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. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Any Serious Adverse Event | Valaciclovir | 0 | participants | ||
| Number of Participants With the Indicated Adverse Drug Reactions | Valaciclovir | Urticaria | 2 | participants | |
| Number of Participants With the Indicated Adverse Drug Reactions | Valaciclovir | Diarrhoea | 1 | participants | |
| Number of Participants With Any Unexpected Adverse Drug Reactions | Valaciclovir | 0 | participants | ||
| Number of Participants Classified as Effective and Not Effective | Valaciclovir | Effective | 347 | participants | |
| Number of Participants Classified as Effective and Not Effective | Valaciclovir | Not effective | 2 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Valaciclovir | 379 | |
| Overall Study | COMPLETED | Valaciclovir | 369 | |
| Overall Study | NOT COMPLETED | Valaciclovir | 10 |
Source ClinicalTrials.gov
Adverse events6
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 | Events |
|---|---|---|---|---|---|---|
| other | Urticaria | Skin and subcutaneous tissue disorders | Valaciclovir | 3 | 369 | |
| other | Diarrhoea | Gastrointestinal disorders | Valaciclovir | 1 | 369 | |
| other | Nasopharyngitis | Infections and infestations | Valaciclovir | 1 | 369 | |
| other | Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | Valaciclovir | 1 | 369 | |
| other | Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | Valaciclovir | 1 | 369 | |
| other | Pruritis | Skin and subcutaneous tissue disorders | Valaciclovir | 1 | 369 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Valaciclovir | ||
| Total, other adverse events | Valaciclovir | 7 | 369 |
| Total, serious adverse events | Valaciclovir | 0 | 369 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT01390857
GET https://conductscience.org/api/trials/v1/NCT01390857/registered