Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-01-06 @ 9:54 PM
Study NCT ID:
NCT03333603
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2017-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenia Patients
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': 'D064098', 'term': 'Esomeprazole'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Investigators will give 40 mg/day esomeprazole in the first two weeks and 80 mg/day from the third week to the end of the trial. Investigators will check the area under the concentration of metabolites of esomeprazoleon Day 1, Day 14 and Day 56 and the genotype of CYP2C19. The GI symptoms and related drug side effects will be evaluated.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-26', 'studyFirstSubmitDate': '2017-01-17', 'studyFirstSubmitQcDate': '2017-11-02', 'lastUpdatePostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Concentration analysis', 'timeFrame': 'It will be assessed on Day 1 predose, Day 14 90 mins post dose, and Day 56 90 mins post dose', 'description': 'The pharmacokinetic parameters for esomeprazole and its main metabolites'}], 'secondaryOutcomes': [{'measure': 'CYP2C19 genotypes analysis', 'timeFrame': 'The genotype will be assessed on Day 1', 'description': 'Investigators will genotype CYP2C19 genotype to determine that which metabolized type (poor metabolizer, intermediate metabolizer, and good metabolizer) of patients belong to.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Schizophrenia'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'To evaluate the pharmacokinetic and safety for the esomeprazole use for schizophrenia', 'detailedDescription': 'Investigators prepare to recruit 30 schizophrenia patients in one year. Investigators will conduct a 8-week open label clinical trial for evaluation of the pharmacokinetic and safety of esomeprazole use for the schizophrenia. Investigators will give 40 mg/day esomeprazole in the first two weeks and 80 mg/day from the third week to the end of the trial. Investigators will check the area under the concentration of metabolites of esomeprazole on Day 1, Day 14 and Day 56 and the genotype of CYP2C19. The GI symptoms and related drug side effects will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. 20-65 years old\n2. Diagnosed as DSM-IV schizophrenia\n3. No adjustment of dose of major antipsychotics for at least 4 weeks\n4. Competence for inform consent\n\nExclusion criteria\n\n1. Diagnosed with schizoaffective disorder or bipolar affective disorder or organic psychotic disorder\n2. Meet the diagnostic criteria of any substance abuse or dependence in the past 6 months\n3. History or evidence of any clinically significant medical or neurological disease, such as autoimmune disease, cancer, epilepsy, etc.\n4. Mental retardation or pervasive developmental disorders\n5. Past history of allergy to Esomeprazole\n6. patient who is taking clozapineć Depakin or Diazepam\n7. Pregnant\n8. The patient is under the order of involuntary admission'}, 'identificationModule': {'nctId': 'NCT03333603', 'briefTitle': 'Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenia Patients', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenic Patients', 'orgStudyIdInfo': {'id': '201601070MIND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'esomeprazole', 'description': 'esomeprazole 40mg /tab oral Day1-Day14 then 40mg/2 tab oral Day15-Day56', 'interventionNames': ['Drug: esomeprazole']}], 'interventions': [{'name': 'esomeprazole', 'type': 'DRUG', 'otherNames': ['Nexium'], 'description': 'esomeprazole 40mg /tab oral Day1-Day14 then 40mg/2 tab oral Day15-Day56', 'armGroupLabels': ['esomeprazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10048', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital Yunlin Branch', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Chih-Min Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Visiting Staff'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Taiwan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}