Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-01-01 @ 9:17 AM
Study NCT ID:
NCT04505657
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2020-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lidocaine Spray Plus Oral Celecoxib for Pain Control During Hysterosalpingography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'randomized controlled trial'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2020-08-06', 'studyFirstSubmitQcDate': '2020-08-06', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean pain score during the procedure', 'timeFrame': '10 minuets', 'description': 'Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IUCD Complication']}, 'descriptionModule': {'briefSummary': 'our aims to investigate the effectiveness of10% Lidocaine Spray plus oral celecoxib for Pain Control During Hysterosalpingography', 'detailedDescription': 'hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the cannula; and injection of the dye'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'female request hystrosalpingogram', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any patient came for Hysterosalpingography\n\nExclusion Criteria:\n\n* any patient has contraindication to Hysterosalpingography'}, 'identificationModule': {'nctId': 'NCT04505657', 'briefTitle': 'Lidocaine Spray Plus Oral Celecoxib for Pain Control During Hysterosalpingography', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University Hospital'}, 'officialTitle': 'Lidocaine Spray Plus Oral Celecoxib for Pain Control During Hysterosalpingography: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'aswu/351/5/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Celecoxib plus lidocaine', 'description': 'Celecoxib 200 mg (Celebrex® 200, Pfizer,USA) administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure', 'interventionNames': ['Drug: celecoxib plus lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Celecoxib', 'description': 'Celecoxib 200 mg (Celebrex® 200, Pfizer,USA) administered orally 2 h before the procedure +Sterile water 4 puffs during the procedure', 'interventionNames': ['Drug: Celecoxib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lidocaine', 'description': 'placebo to celecoxib administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure', 'interventionNames': ['Drug: lidocaine']}], 'interventions': [{'name': 'celecoxib plus lidocaine', 'type': 'DRUG', 'otherNames': ['experimental'], 'description': 'Celecoxib 200 mg (Celebrex® 200, Pfizer,USA) administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure', 'armGroupLabels': ['Celecoxib plus lidocaine']}, {'name': 'Celecoxib', 'type': 'DRUG', 'otherNames': ['Active Comparator'], 'description': 'Celecoxib 200 mg (Celebrex® 200, Pfizer,USA) administered orally 2 h before the procedure +Sterile water 4 puffs during the procedure', 'armGroupLabels': ['Celecoxib']}, {'name': 'lidocaine', 'type': 'DRUG', 'otherNames': ['Active Comparato'], 'description': 'placebo to celecoxib administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure', 'armGroupLabels': ['lidocaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81528', 'city': 'Aswān', 'country': 'Egypt', 'facility': 'Aswan University Hospital', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}], 'overallOfficials': [{'name': 'nahla w Shady, md', 'role': 'STUDY_CHAIR', 'affiliation': 'Aswan universirty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'A Professor', 'investigatorFullName': 'hany farouk', 'investigatorAffiliation': 'Aswan University Hospital'}}}}