Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT00324051
Status:
COMPLETED
Last Update Posted:
2019-09-12
First Post:
2006-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patient's Preference Between Conventional Oral Olanzapine Tablet vs Olanzapine Orodispersible Tablet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Israel', 'Mexico', 'Netherlands']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 284}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2006-05-08', 'studyFirstSubmitQcDate': '2006-05-08', 'lastUpdatePostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient preference measured by a simple preference question.'}], 'secondaryOutcomes': [{'measure': 'Better treatment adherence as measured by DAI-10'}, {'measure': 'Safety and tolerability as measured by AMDP-5'}, {'measure': 'Determine the predictors of drug compliance'}, {'measure': 'Mean change from baseline to endpoint in body mass index (BMI)'}, {'measure': 'Compare serum ghrelin levels'}, {'measure': 'Differences in subjective appetite from baseline to endpoint using a visual analog scale (VAS)'}, {'measure': 'Effect on the medication compliance, level of medication supervision, and willingness to remain on medication, as measured by Medication Adherence Form (MAF)'}, {'measure': 'Patient preference of the paranoid sub population as measured by a simple preference question'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '20653494', 'type': 'RESULT', 'citation': "Bitter I, Treuer T, Dilbaz N, Oyffe I, Ciorabai EM, Gonzalez SL, Ruschel S, Salburg J, Dyachkova Y. Patients' preference for olanzapine orodispersible tablet compared with conventional oral tablet in a multinational, randomized, crossover study. World J Biol Psychiatry. 2010 Oct;11(7):894-903. doi: 10.3109/15622975.2010.505663."}], 'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to estimate drug preference of stable schizophrenic patients who will be treated with olanzapine orodispersible tablets for 6 weeks then with olanzapine tablets for 6 weeks and vice-versa.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* You are an outpatient diagnosed with stable schizophrenia.\n* You are a male or female in the age of 18 to 65 years old.\n* You are retrospectively judged by investigators, based on clinical interview and impression, to have been stable for at least 4 weeks.\n* You must be able to take olanzapine orodispersible in a single daily dose.\n* You are treated with conventional oral olanzapine tablet (as monotherapy) for at least 1 month.\n\nExclusion Criteria:\n\n* You have used olanzapine in the past and are no longer using it because of a bad reaction.\n* You have known Human immunodeficiency virus positive (HIV+) status.\n* You have known uncorrected, narrow angle glaucoma.\n* You have known Leukopenia, (abnormally low white blood cell count).\n* You have a serious or uncontrolled illness (for example: liver disease, history of heart disease, or inadequately controlled diabetes.)\n* You have Parkinson's disease.\n* You are a female patient who is either pregnant or nursing\n* You are taking medications that are not allowed in the study."}, 'identificationModule': {'nctId': 'NCT00324051', 'acronym': 'PREFERENCE', 'briefTitle': "Patient's Preference Between Conventional Oral Olanzapine Tablet vs Olanzapine Orodispersible Tablet", 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'PREFERENCE: 12-Week Open Label Trial On Olanzapine Orodispersible Tablet Vs. Oral Olanzapine Preference Study', 'orgStudyIdInfo': {'id': '10960'}, 'secondaryIdInfos': [{'id': 'F1D-VI-S067', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'olanzapine therapy', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21020-130', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'Constanța', 'country': 'Romania', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.18073, 'lon': 28.63432}}, {'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}, {'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '16045', 'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}, {'zip': '23800', 'city': 'Elâzığ', 'country': 'Turkey (Türkiye)', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.67431, 'lon': 39.22321}}, {'city': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}, {'zip': '34390', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}