Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-17 @ 4:33 AM
Study NCT ID:
NCT05648058
Status:
UNKNOWN
Last Update Posted:
2022-12-15
First Post:
2022-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Nefopam in Rituximab Transfusion Reaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009340', 'term': 'Nefopam'}], 'ancestors': [{'id': 'D010079', 'term': 'Oxazocines'}, {'id': 'D001392', 'term': 'Azocines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-12-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-11-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-13', 'studyFirstSubmitDate': '2022-12-04', 'studyFirstSubmitQcDate': '2022-12-04', 'lastUpdatePostDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'transfusion reaction', 'timeFrame': '30 min', 'description': 'fever, riger, rash, chills, pruritus and bronchospasm'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nefopam']}, 'descriptionModule': {'briefSummary': 'the patients will be taken nefopam ampule 50 mg before rituximab in the first group while the second group will be taken diphenhydramine ampule 10 mg before rituximab in the second group', 'detailedDescription': 'the two groups will be taken standard therapy (hydrocortisone vial 100 mg and acetaminophen 1000 mg) 30 min before rituximab'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 - 80 years old male and female will be taken rituximab\n\nExclusion Criteria:\n\n* less than 18 years old more than 80 years old diabetic patients'}, 'identificationModule': {'nctId': 'NCT05648058', 'briefTitle': 'Role of Nefopam in Rituximab Transfusion Reaction', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ministry Of Health / Nineveh Health Directorate'}, 'officialTitle': 'Role of Nefopam in Rituximab Transfusion Reaction', 'orgStudyIdInfo': {'id': 'nefopam with rituximab'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nefopam', 'description': 'administration of intravenous nefopam to prevent Rituximab Transfusion Reaction', 'interventionNames': ['Drug: Nefopam ampule']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'diphenhydramine', 'description': 'administration of intravenous diphenhydramine to prevent Rituximab Transfusion Reaction', 'interventionNames': ['Drug: diphenhydramine ampule']}], 'interventions': [{'name': 'Nefopam ampule', 'type': 'DRUG', 'otherNames': ['ACUPAN'], 'description': 'nefopam ampule 50 mg', 'armGroupLabels': ['nefopam']}, {'name': 'diphenhydramine ampule', 'type': 'DRUG', 'otherNames': ['Allermine'], 'description': 'diphenhydramine ampule 10 mg', 'armGroupLabels': ['diphenhydramine']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'fakhraldin marwan', 'role': 'CONTACT', 'email': 'drfakhralin@gmail.com', 'phone': '07817639470'}, {'name': 'zainab thanon', 'role': 'CONTACT', 'email': 'zainabthanon@gmail.com', 'phone': '07518097301'}], 'overallOfficials': [{'name': 'moataz alani', 'role': 'STUDY_CHAIR', 'affiliation': 'Ministry Of Health / Nineveh Health Directorate'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ministry Of Health / Nineveh Health Directorate', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}