Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-02 @ 4:24 PM
Study NCT ID:
NCT05645302
Status:
UNKNOWN
Last Update Posted:
2022-12-09
First Post:
2022-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Monitoring Scheme of Lidocaine Cataplasms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-07', 'studyFirstSubmitDate': '2022-11-22', 'studyFirstSubmitQcDate': '2022-12-07', 'lastUpdatePostDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': 'January 1, 2021 - April 1, 2022', 'description': 'Past medical history and other diseases that the researcher thinks have clinical significance. Collect the frequency, type, years, etc. of drinking and/or smoking, as well as the family history of diseases. Including white blood cell, red blood cell, hemoglobin, platelet count, etc. Including white blood cells, red blood cells, urine protein, urine sugar, etc. Including ALT, AST, ALP, TBil, GGT, BUN, Cr, etc. The researcher issued a prescription of lidocaine gel plaster according to the drug instructions, and recorded the indications, medication time, dose, frequency, drug batch number, etc. It includes all kinds of reactions unrelated to the treatment purpose during the study period, including symptoms, signs, laboratory abnormalities with clinical significance or special examinations.administration or discharge.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adverse Reaction to Drug']}, 'descriptionModule': {'briefSummary': 'In this center, retrospective research methods are used to collect data. Patients who had used Lidocaine Cataplasms at least once were included consecutively. Taking the time when the patient first used Lidocaine Cataplasms as the starting time (the study baseline), collect the demographic characteristics of the patient, the medication scheme of Lidocaine Cataplasms and other information, as well as the medication safety and other information from the first medication to the end of medication or discharge (whichever occurs first).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have used Lidocaine Cataplasms at least 1 consecutive time between January 1, 2021 and April 1, 2022.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients receiving Lidocaine Cataplasms from January 1, 2021 to April 1, 2022.\n\nExclusion Criteria:\n\n* Unable to obtain complete medication information.'}, 'identificationModule': {'nctId': 'NCT05645302', 'briefTitle': 'Intensive Monitoring Scheme of Lidocaine Cataplasms', 'organization': {'class': 'OTHER', 'fullName': 'Qianfoshan Hospital'}, 'officialTitle': 'Intensive Monitoring Scheme of Lidocaine Cataplasms', 'orgStudyIdInfo': {'id': 'ZT-DBN-ZDJC-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients using Lidocaine Cataplasms', 'interventionNames': ['Drug: Lidocaine Cataplasms']}], 'interventions': [{'name': 'Lidocaine Cataplasms', 'type': 'DRUG', 'description': 'The main ingredient of this product is lidocaine, the cream surface is white or almost white, the cream is evenly spread on the back, and the cream surface is covered with film.', 'armGroupLabels': ['Patients using Lidocaine Cataplasms']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250014', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'wei Xu, PHD', 'role': 'CONTACT', 'email': 'weixu@sdu.edu.cn', 'phone': '86-17686791319'}], 'facility': 'The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Wei Xu, MD', 'role': 'CONTACT', 'email': 'weixu@sdu.edu.cn', 'phone': '17686791319'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qianfoshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Wei Xu', 'investigatorAffiliation': 'Qianfoshan Hospital'}}}}