Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-01-12 @ 2:53 AM
Study NCT ID:
NCT02020902
Status:
COMPLETED
Last Update Posted:
2016-05-16
First Post:
2013-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Marketing Surveillance for Contac Bien Z in Japan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1552}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-12', 'studyFirstSubmitDate': '2013-12-19', 'studyFirstSubmitQcDate': '2013-12-19', 'lastUpdatePostDateStruct': {'date': '2016-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events after having cetrizine hydrochloride', 'timeFrame': 'At baseline', 'description': 'Participants will answer a questionnaire which consists of questions on safety of the marketed cetrizine hydrochloride formulation.'}], 'secondaryOutcomes': [{'measure': 'Efficacy of the marketed cetrizine hydrochloride formulation', 'timeFrame': 'At baseline', 'description': 'Participants will answer a questionnaire which consists of questions on their satisfaction after taking the marketed cetrizine hydrochloride formulation. The efficacy will be measured on a 4 point scale (1 Efficacious; 2 Somewhat efficacious; 3 Not efficacious; 4 Not known)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergic Rhinitis', 'Seasonal Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'This is a post-marketing surveillance study on a marketed cetrizine hydrochloride formulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants who purchase the marketed cetrizine hydrochloride formulation from pharmacy stores in Japan.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female participants, between 15-65 years of age, who purchase the marketed cetrizine hydrochloride formulation\n\nExclusion Criteria:\n\n* Who have ever experienced allergic symptoms by taking this medication or any component of this medication, piperazine derivative (including levocetirizine, hydroxizine)\n* Those who have been under 15en diagnosed with kidney disease\n* Children under 15 years of age'}, 'identificationModule': {'nctId': 'NCT02020902', 'briefTitle': 'Post Marketing Surveillance for Contac Bien Z in Japan', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Contac Bien Z Adverse Effect Survey', 'orgStudyIdInfo': {'id': '200638'}, 'secondaryIdInfos': [{'id': 'RH01905', 'type': 'OTHER', 'domain': 'GSK'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Cetrizine hydrochloride', 'type': 'OTHER', 'description': 'As provided on the patient information leaflet'}]}, 'contactsLocationsModule': {'locations': [{'zip': '340-0144', 'city': 'Saitama', 'country': 'Japan', 'facility': 'Drug Store Seki', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}