Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-28 @ 7:31 PM
Study NCT ID:
NCT01271257
Status:
COMPLETED
Last Update Posted:
2016-01-28
First Post:
2011-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Misoprostol With Titrated Oral Administration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016595', 'term': 'Misoprostol'}], 'ancestors': [{'id': 'D011459', 'term': 'Prostaglandins E, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-27', 'studyFirstSubmitDate': '2011-01-05', 'studyFirstSubmitQcDate': '2011-01-05', 'lastUpdatePostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC480 (the area under the curve of serum concentration of misoprostol acid against time up to 480 minutes)', 'timeFrame': '480 min post start of oral misoprostol administration'}], 'secondaryOutcomes': [{'measure': 'AUC240 (the area under the curve of serum concentration of misoprostol acid against time up to 240 minutes)', 'timeFrame': '240 min post start of oral misoprostol administration'}, {'measure': 'AUC360 (the area under the curve of serum concentration of misoprostol acid against time up to 360 minutes)', 'timeFrame': '360 min post start of oral misoprostol administration'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['misoprostol, pharmacokinetics'], 'conditions': ['Hypotonic; Labor']}, 'referencesModule': {'references': [{'pmid': '11821273', 'type': 'BACKGROUND', 'citation': 'Tang OS, Schweer H, Seyberth HW, Lee SW, Ho PC. Pharmacokinetics of different routes of administration of misoprostol. Hum Reprod. 2002 Feb;17(2):332-6. doi: 10.1093/humrep/17.2.332.'}, {'pmid': '9207820', 'type': 'BACKGROUND', 'citation': 'Zieman M, Fong SK, Benowitz NL, Banskter D, Darney PD. Absorption kinetics of misoprostol with oral or vaginal administration. Obstet Gynecol. 1997 Jul;90(1):88-92. doi: 10.1016/S0029-7844(97)00111-7.'}], 'seeAlsoLinks': [{'url': 'http://www.bh.cmu.edu.tw/cmubh/ch/index.php', 'label': 'China Medical University Beigang Hospital'}]}, 'descriptionModule': {'briefSummary': 'The AUC240, AUC360, and AUC480 of titrated oral misoprostol are greater than traditional oral misoprostol.', 'detailedDescription': 'The primary outcomes measures of the study are the area under the curve of serum concentration of misoprostol acid against time up to 240, 360 and 480 minutes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20-40 Y/O healthy and non-pregnant woman\n\nExclusion Criteria:\n\n* heart, liver or kidney disease, anaphylaxis to misoprostol'}, 'identificationModule': {'nctId': 'NCT01271257', 'briefTitle': 'Pharmacokinetics of Misoprostol With Titrated Oral Administration', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Phase 1 Study of Titrated Oral Misoprostol', 'orgStudyIdInfo': {'id': 'CMUBH R990011'}, 'secondaryIdInfos': [{'id': 'DMR-IRB-242', 'type': 'OTHER', 'domain': 'China Medical University Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hourly misoprostol', 'description': '20 microgram misoprostol intake per hour', 'interventionNames': ['Drug: Misoprostol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'traditional misoprostol', 'description': '80 microgram misoprostol intake per 4 hours', 'interventionNames': ['Drug: Misoprostol']}], 'interventions': [{'name': 'Misoprostol', 'type': 'DRUG', 'otherNames': ['cytotec'], 'description': '20 microgram PO per hour for 8 doses or 80 microgram PO per 4 hours for 2 doses', 'armGroupLabels': ['hourly misoprostol', 'traditional misoprostol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '651', 'city': 'Yunlin Xian', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'China Medical University Beigang Hospital'}], 'overallOfficials': [{'name': 'Shi-Yann Cheng, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China Medical University Beigang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Department of Obstetrics and Gynecology', 'investigatorFullName': 'Shi-Yann Cheng', 'investigatorAffiliation': 'China Medical University Hospital'}}}}