Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-25 @ 4:23 PM
Study NCT ID:
NCT01390857
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2011-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002644', 'term': 'Chickenpox'}], 'ancestors': [{'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077483', 'term': 'Valacyclovir'}], 'ancestors': [{'id': 'D000212', 'term': 'Acyclovir'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Valaciclovir', 'description': '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.', 'otherNumAtRisk': 369, 'otherNumAffected': 7, 'seriousNumAtRisk': 369, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 369, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Any Serious Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Valaciclovir', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Safety Population: all participants to whom the drug was administered, excluding 10 withdrawal participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Adverse Drug Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Valaciclovir', 'description': '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.'}], 'classes': [{'title': 'Urticaria', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhoea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Safety Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Unexpected Adverse Drug Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Valaciclovir', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Safety Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants Classified as Effective and Not Effective', 'denoms': [{'units': 'Participants', 'counts': [{'value': '349', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Valaciclovir', 'description': '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.'}], 'classes': [{'title': 'Effective', 'categories': [{'measurements': [{'value': '347', 'groupId': 'OG000'}]}]}, {'title': 'Not effective', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': '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."', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Valaciclovir', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '379'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '369'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'No Visit after the First Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}], 'preAssignmentDetails': 'This post-marketing surveillance (PMS) study was designed to evaluate the safety and efficacy of valaciclovir in pediatric participants with chickenpox.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Valaciclovir', 'description': '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.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '>=1 month to <1 year', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}, {'title': '>=1 to <7 years', 'categories': [{'measurements': [{'value': '311', 'groupId': 'BG000'}]}]}, {'title': '>=7 to <=13 years', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The number of participants in the indicated age groups was recorded. Baseline characteristics were collected in members of the Intent-to-Treat Safety Population, comprised of all participants to whom the drug was administered, excluding 10 withdrawal participants.', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '156', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '213', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Baseline characteristics were collected in members of the Intent-to-Treat Safety Population, comprised of all participants to whom the drug was administered, excluding 10 withdrawal participants.', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Japanese', 'categories': [{'measurements': [{'value': '369', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Baseline characteristics were collected in members of the Intent-to-Treat Safety Population, comprised of all participants to whom the drug was administered, excluding 10 withdrawal participants.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 379}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-15', 'studyFirstSubmitDate': '2011-07-07', 'resultsFirstSubmitDate': '2011-08-18', 'studyFirstSubmitQcDate': '2011-07-07', 'lastUpdatePostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-08-18', 'studyFirstPostDateStruct': {'date': '2011-07-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Any Serious Adverse Event', 'timeFrame': '1 month', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With the Indicated Adverse Drug Reactions', 'timeFrame': '1 month', 'description': '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.'}, {'measure': 'Number of Participants With Any Unexpected Adverse Drug Reactions', 'timeFrame': '1 month', 'description': '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.'}, {'measure': 'Number of Participants Classified as Effective and Not Effective', 'timeFrame': '1 month', 'description': '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."'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Varicella']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Japanese pediatric patients with chickenpox (aged less than 15 years old)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients with chickenpox (aged less than 15 years old).\n\nExclusion Criteria:\n\n* Patients with a history of hypersensitivity to the ingredients of valaciclovir or acyclovir.'}, 'identificationModule': {'nctId': 'NCT01390857', 'briefTitle': 'Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)', 'orgStudyIdInfo': {'id': '112323'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric patients prescribed valaciclovir', 'description': 'Pediatric patients with chickenpox prescribed valaciclovir during study period.', 'interventionNames': ['Drug: Valaciclovir']}], 'interventions': [{'name': 'Valaciclovir', 'type': 'DRUG', 'armGroupLabels': ['Pediatric patients prescribed valaciclovir']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}