Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT00725218
Status:
COMPLETED
Last Update Posted:
2008-08-06
First Post:
2008-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Flurbiprofen Axetil for Uterine Contraction Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077331', 'term': "Ringer's Solution"}, {'id': 'C504422', 'term': 'flurbiprofen axetil'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, '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': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-08-05', 'studyFirstSubmitDate': '2008-07-28', 'studyFirstSubmitQcDate': '2008-07-28', 'lastUpdatePostDateStruct': {'date': '2008-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS pain scorings', 'timeFrame': 'At the end of the operation, 0,5,15,30,60min after operation'}], 'secondaryOutcomes': [{'measure': 'Anesthetic consumptions', 'timeFrame': 'At the end of the operation'}, {'measure': 'Overall VAS satisfaction scorings with analgesia', 'timeFrame': 'At the end of the study'}, {'measure': 'Side effects', 'timeFrame': 'During the whole period of the study'}, {'measure': 'Volume of bleeding', 'timeFrame': 'At the end of the study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NSAIDs', 'Postoperative pain', 'Analgesia', 'Abortion'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'Uterine contraction pain is a common problem after abortion. Optimal analgesic for such suffering is still needed to be guaranteed. Flurbiprofen Axetil is a target-distributable non-steroidal anti-inflammatory drug (NSAID) functioning via block the synthesis of prostaglandin E (PGE). The investigators hypothesized that Flurbiprofen Axetil could suppress the uterine contraction pain after abortion effectively.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA status I-II\n* Performing abortion operation (medical- or drug-induced\n* Requiring painless abortion\n\nExclusion Criteria:\n\n* \\< 19yrs, and \\>= 45yrs\n* History of central active drugs administration\n* Drug abuse\n* Hypertension\n* Diabetes\n* Any other chronic diseases\n* Allergy to the study drugs\n* Habit of over-volume alcohol drinking\n* Records of history of centrally active drug use and psychiatry\n* Any organic disorders'}, 'identificationModule': {'nctId': 'NCT00725218', 'acronym': 'FAUCOP', 'briefTitle': 'Flurbiprofen Axetil for Uterine Contraction Pain', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'Phase IV Study of Flurbiprofen Axetil for Uterine Contraction Pain After Abortion', 'orgStudyIdInfo': {'id': 'NMU-MZ203'}, 'secondaryIdInfos': [{'id': 'M089732'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Saline 5 ml injection 10 min prior to propofol administration.', 'interventionNames': ['Drug: Saline']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Flurbiprofen Axetil 50 mg in 5 ml injection 10min prior to propofol administration.', 'interventionNames': ['Drug: Flurbiprofen Axetil']}], 'interventions': [{'name': 'Saline', 'type': 'DRUG', 'otherNames': ["Ringer's solution"], 'description': 'Saline 5 ml injection 10 min prior to propofol administration.', 'armGroupLabels': ['1']}, {'name': 'Flurbiprofen Axetil', 'type': 'DRUG', 'otherNames': ['KaiFen'], 'description': 'Flurbiprofen Axetil 50 mg in 5 ml injection 10min prior to propofol administration.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210004', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Maternal and Child Health Care Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'XiaoFeng Shen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nanjing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'XiaoFeng Shen', 'oldOrganization': 'Nanjing Maternal and Child Health Hospital'}}}}