Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2026-02-25 @ 8:17 PM
Study NCT ID:
NCT02709603
Status:
COMPLETED
Last Update Posted:
2016-09-07
First Post:
2016-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyoscine Butyl Bromide in Reducing Pain During HSG
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002086', 'term': 'Butylscopolammonium Bromide'}], 'ancestors': [{'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-06', 'studyFirstSubmitDate': '2016-03-11', 'studyFirstSubmitQcDate': '2016-03-11', 'lastUpdatePostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean pain score during. hysterosalpingography by visual analog scale', 'timeFrame': 'intraoperative'}], 'secondaryOutcomes': [{'measure': 'Mean pain score after hysterosalpingography', 'timeFrame': '30 minutes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pain Relief With HSG']}, 'descriptionModule': {'briefSummary': "Many oral analgesic drugs such as nonsteroidal anti-inflammatory drug(NSAID) are used to relieve pain from gynecological procedure and dysmenorrhea. Hyoscine-N-butyl bromide, an antispasmodic drug are commonly used for relief of smooth muscle spasms and can use to relieve genito-urinary spasm. Some studies reported hyoscine can't relieve pain in minor gynecological procedures. So the efficacy of hyoscine use are still controversial and no previous studies investigated its efficacy for pain relief in HSG procedure."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe infertile women who indicated for HSG.\n\nExclusion Criteria:\n\n* contraindications to Hyoscine or NSAID - known sensitivity to these drugs\n* known sensitivity to contrast media\n* abnormal uterine bleeding\n* genital tract infection\n* suspected pregnancy'}, 'identificationModule': {'nctId': 'NCT02709603', 'acronym': 'HBTB-DIC', 'briefTitle': 'Hyoscine Butyl Bromide in Reducing Pain During HSG', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Randomized Clinical Trial of Oral Hyoscine Butyl Bromide in Reducing Pain During HSG', 'orgStudyIdInfo': {'id': 'HS2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'oral hyoscine butyl bromide; 2 tablets (buscopan 10 mg) 30 minutes before the procedure', 'interventionNames': ['Drug: hyoscine butyl bromide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B', 'description': 'oral 2 tablets (PLACEBO) 30 minutes before the procedure', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'hyoscine butyl bromide', 'type': 'DRUG', 'otherNames': ['BUSCOPAN'], 'description': 'oral hyoscine butyl bromide; 2 tablets (buscopan 10 mg) 30 minutes before the procedure', 'armGroupLabels': ['Group A']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'oral placebo; 2 tablets 30 minutes before the procedure', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Assiut', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Ahmed Abbas'}, {'zip': '002', 'city': 'Asyut', 'state': 'Please Select', 'country': 'Egypt', 'facility': 'Ahmed Abbas', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'ahmed abbas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Woman health hospital Assiut'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Ahmed Mohamed Abbas', 'investigatorAffiliation': 'Assiut University'}}}}