Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-02-24 @ 5:03 PM
Study NCT ID:
NCT02710305
Status:
COMPLETED
Last Update Posted:
2017-01-10
First Post:
2016-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Hyoscine Butyl Bromide With Cervical Lidocaine Cream in Reducing Pain During Hysterosalpingography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-08', 'studyFirstSubmitDate': '2016-03-11', 'studyFirstSubmitQcDate': '2016-03-11', 'lastUpdatePostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean pain score during HSG', 'timeFrame': 'intraoperative'}], 'secondaryOutcomes': [{'measure': 'Mean pain score after HSG', 'timeFrame': '30 minutes'}, {'measure': 'rate of side effects', 'timeFrame': '30 minutes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pain Relief']}, 'descriptionModule': {'briefSummary': 'hysterosalpingography is a diagnosis procedure in the evaluation of infertile women and considered to be the traditional and the gold standard in the assessment of the patency of the fallopian tubes. The major disadvantage of hysterosalpingography is pain. In a study reported the patients complained of moderate to severe pain during the procedure. It is reported that some patients undergoing hysterosalpingography was more stressful and anxiety and effect on pain scores.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• The infertile women who indicated for HSG\n\nExclusion Criteria:\n\n* contraindications to Hyoscine or lidocaine\n* known sensitivity to contrast media\n* abnormal uterine bleeding\n* genital tract infection\n* suspected pregnancy'}, 'identificationModule': {'nctId': 'NCT02710305', 'acronym': 'HBTB', 'briefTitle': 'Oral Hyoscine Butyl Bromide With Cervical Lidocaine Cream in Reducing Pain During Hysterosalpingography', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Randomized Clinical Trial of Oral Hyoscine Butyl Bromide With Cervical Lidocaine Cream in Reducing Pain During Hysterosalpingography', 'orgStudyIdInfo': {'id': 'HS1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'oral hyoscine butyl bromide tablets plus lidocaine cream', 'interventionNames': ['Drug: oral hyoscine butyl bromide tablets plus lidocaine cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B', 'description': 'oral placebo tablets plus placebo cream', 'interventionNames': ['Drug: oral placebo tablets plus placebo cream']}], 'interventions': [{'name': 'oral hyoscine butyl bromide tablets plus lidocaine cream', 'type': 'DRUG', 'description': 'patients will take oral hyoscine butyl bromide 30 minutes before the procedure plus lidocaine anesthetic cream placed into their cervix immediately before the procedure', 'armGroupLabels': ['Group A']}, {'name': 'oral placebo tablets plus placebo cream', 'type': 'DRUG', 'description': 'patients will take oral placebo 30 minutes before the procedure plus placebo cream placed into their cervix immediately before the procedure', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Assiut', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Ahmed Abbas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Ahmed Mohamed Abbas', 'investigatorAffiliation': 'Assiut University'}}}}