Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-28 @ 2:05 PM
Study NCT ID:
NCT01371435
Status:
COMPLETED
Last Update Posted:
2017-06-08
First Post:
2011-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Use Investigation for PAXIL Tablet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017374', 'term': 'Paroxetine'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3708}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-07', 'studyFirstSubmitDate': '2011-06-09', 'studyFirstSubmitQcDate': '2011-06-09', 'lastUpdatePostDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice', 'timeFrame': '8 weeks'}, {'measure': 'Presence/absence of concomitant use of drugs metabolized by CYP2D6', 'timeFrame': 'Within 2 weeks after discontinuation or completion of treatment', 'description': 'PAXIL inhibits drug-metabolizing enzyme CYP2D6, and it takes about 1 week following discontinuation of PAXIL for this CYP2D6 function to recover from the inhibiting effect. Since it requires attention if drugs that are metabolized by CYP2D6 are administered during this recovery period, it was decided to investigate the presence/absence of use of drugs metabolized by CYP2D6 within 2 weeks after discontinuation of treatment in patients for whom treatment with PAXIL was discontinued, as well as the safety thereof.'}, {'measure': 'Presence/absence of concomitant use of products containing Saint John\'s Wort (Hypericum perforatum; "SJW", hereinafter)', 'timeFrame': '8 weeks', 'description': 'Although the action mechanism for this is not clear, SJW has been reported to have the action of inhibiting reuptake of serotonin, noradrenaline and dopamine, and to exhibit an antidepressant effect. Since PAXIL also acts to inhibit serotonin reuptake, concomitant use of products containing SJW is thought to have an effect upon the serotonin reuptake inhibiting action of PAXIL, so it was decided to check for concomitant use of products containing SJW and investigate the safety of such concomitant use.'}]}, 'conditionsModule': {'conditions': ['Mental Disorders']}, 'descriptionModule': {'briefSummary': 'This post-marketing surveillance study is designed to detect adverse events (particularly clinically significant adverse drug reactions) occurring in clinical settings and to examine factors likely to affect the safety and efficacy of paroxetine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Japanese subjects with depression/depressed state or panic disorder who were indicated for PAXIL', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with depression/depressed state or panic disorder\n\nExclusion Criteria:\n\n* Patients who had been taking PAXIL since before the start of the survey\n* Patients with hypersensitivity to paroxetine\n* Patients taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs\n* Concomitant use in patients taking pimozide'}, 'identificationModule': {'nctId': 'NCT01371435', 'briefTitle': 'Drug Use Investigation for PAXIL Tablet', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Drug Use Investigation for PAXIL Tablet', 'orgStudyIdInfo': {'id': '112301'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients prescribed PAXIL', 'description': 'Patients with depression/depressed state or panic disorder prescribed PAXIL during study period', 'interventionNames': ['Drug: Paroxetine']}], 'interventions': [{'name': 'Paroxetine', 'type': 'DRUG', 'armGroupLabels': ['Patients prescribed PAXIL']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}