Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-02-06 @ 11:16 AM
Study NCT ID:
NCT02137993
Status:
COMPLETED
Last Update Posted:
2014-05-14
First Post:
2014-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077152', 'term': 'Olanzapine'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-11', 'studyFirstSubmitDate': '2014-05-11', 'studyFirstSubmitQcDate': '2014-05-11', 'lastUpdatePostDateStruct': {'date': '2014-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline at 6 week in total PANSS score', 'timeFrame': '6 week'}], 'secondaryOutcomes': [{'measure': 'Change from baseline at 1, 2, 4 and 6 week in total PANSS score.', 'timeFrame': '6 week'}, {'measure': 'Responder to be decreased of 30% or more in PANSS total score from baseline at 6 week', 'timeFrame': '6 week'}, {'measure': 'Change from baseline at 6 week in total CGI-S score', 'timeFrame': '6 week'}, {'measure': "Responder rate in CGI-I score of 'very much improved', 'much improved' and 'minimally improved'", 'timeFrame': '6 week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Schizophreniform Disorder', 'Schizoaffective Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of A-prexa compared to Zyprexa in patients with schizophrenia, schizophreniform disorder and schizoaffective disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20 years to 65 years\n* Schizophrenia patient with an acute exacerbation\n* Understand the requirement of the study and voluntarily consent to participate in the study\n\nExclusion Criteria:\n\n* Patients who have another psychiatric disorders\n* Patients who have unstable medical conditions\n* Patients who have clinically important abnormalities of liver function test (\\>2.5 fold of upper normal limit), ECG and vital sign at screening visit\n* Uncontrolled diabetic patients (plasma glucose level is more than 126 mg/dl in fasting condition)\n* Patients who have a history of an allergic reaction to olanzapine\n* Patient who have no clinical response to take two or more different atypical anti-psychotics for more than 4 weeks.\n* Patient who take clozapine within 12 weeks before screening visit'}, 'identificationModule': {'nctId': 'NCT02137993', 'briefTitle': 'Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'HK inno.N Corporation'}, 'officialTitle': 'A Multi-center, Randomized, Double Blind, Parallel, Phaseâ…£ Trial to Evaluate the Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia, Schizophreniform Disorder and Schizoaffective Disorder', 'orgStudyIdInfo': {'id': 'CJ_OLZ_401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A-prexa', 'description': 'A-prexa 5, 10mg', 'interventionNames': ['Drug: Zyprexa']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Zyprexa', 'description': 'Zyprexa 5, 10mg', 'interventionNames': ['Drug: A-prexa']}], 'interventions': [{'name': 'A-prexa', 'type': 'DRUG', 'description': 'A-prexa 5-20 mg for 6 weeks', 'armGroupLabels': ['Zyprexa']}, {'name': 'Zyprexa', 'type': 'DRUG', 'description': 'Zyprexa 5-20 mg for 6 weeks', 'armGroupLabels': ['A-prexa']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HK inno.N Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}