Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT00101569
Status:
COMPLETED
Last Update Posted:
2013-11-08
First Post:
2005-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aripiprazole Oral Acceptability Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068180', 'term': 'Aripiprazole'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-07', 'studyFirstSubmitDate': '2005-01-12', 'studyFirstSubmitQcDate': '2005-01-12', 'lastUpdatePostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'acceptability'}]}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to study liquid aripiprazole in patients with stable schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable patients currently receiving aripiprazole or other antipsychotic medications.'}, 'identificationModule': {'nctId': 'NCT00101569', 'briefTitle': 'Aripiprazole Oral Acceptability Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'officialTitle': 'Aripiprazole Oral Acceptability Trial', 'orgStudyIdInfo': {'id': 'CN138-091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A1', 'interventionNames': ['Drug: Aripiprazole']}, {'type': 'EXPERIMENTAL', 'label': 'A2', 'interventionNames': ['Drug: Aripiprazole']}], 'interventions': [{'name': 'Aripiprazole', 'type': 'DRUG', 'otherNames': ['Abilify'], 'description': 'Tablets, Oral, 15 -30 mg, once daily, 2 weeks (days 1 -14).', 'armGroupLabels': ['A1']}, {'name': 'Aripiprazole', 'type': 'DRUG', 'otherNames': ['Abilify'], 'description': 'Oral Solution, Oral, 15-30 ml, once daily, 1 week (days 15 -21).', 'armGroupLabels': ['A2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'National City', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'city': 'North Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 25.93315, 'lon': -80.16255}}, {'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Development & Commercialization, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Otsuka America Pharmaceutical', 'class': 'INDUSTRY'}]}}}