Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 11:10 PM
Study NCT ID:
NCT04049734
Status:
COMPLETED
Last Update Posted:
2019-08-09
First Post:
2019-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Losartan in Prevention of Post-ERCP Paancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-08', 'studyFirstSubmitDate': '2019-08-03', 'studyFirstSubmitQcDate': '2019-08-06', 'lastUpdatePostDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with development of acute pancreatitis', 'timeFrame': '24 hours', 'description': 'Number of participants with development of abdominal pain and elevated serum amylase and/or lipase'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-ERCP Acute Pancreatitis']}, 'descriptionModule': {'briefSummary': 'Oral losartan given in the dose of 50 mg one hour before ERCP was studied in the prevention of post ERCP pancreatitis in 50 patients indicated for ERCP in comparison with another 50 patients underwent ERCP without receiving oral losartan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any adult patient indicated for ERCP\n* Patients with obstructive jaundice.\n* Patients with dilated intra-hepatic or extra-hepatic bile ducts due to malignant or benign lesions.\n\nExclusion Criteria:\n\n* Patients refusing to undergo the procedure or signing the informed consent\n* Patients with clinically evident acute pancreatitis before the procedure\n* Patients with previous endoscopic or surgical sphincterotomy\n* Patients with current use of losartan\n* Patients who are allergic or hypersensitive to losartan or hydro soluble contrast solutions\n* Patients receiving NSAIDS within a week prior to assessment\n* Patients with severe co-morbid conditions as cardiovascular disease, renal failure or decompensated liver cirrhosis.'}, 'identificationModule': {'nctId': 'NCT04049734', 'briefTitle': 'Oral Losartan in Prevention of Post-ERCP Paancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Evaluation of Oral Losartan in the Prevention of Post-ERCP Pancreatitis', 'orgStudyIdInfo': {'id': '689'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'patients received the oral losartan', 'description': '50 patients with obstructive jaundice indicated for ERCP and received oral losartan 1 hour before ERCP as a prophylaxis of post-ERCP pancreatitis', 'interventionNames': ['Drug: oral losatan']}, {'type': 'NO_INTERVENTION', 'label': "patients didn't receive the oral losartan", 'description': "50 patients with obstructive jaundice indicated for ERCP and didn't receive any prophylactic drugs"}], 'interventions': [{'name': 'oral losatan', 'type': 'DRUG', 'description': '50 mg of oral losartan one hour before the ERCP once', 'armGroupLabels': ['patients received the oral losartan']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Shereen Abou Bakr Saleh', 'investigatorAffiliation': 'Ain Shams University'}}}}