Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-03 @ 1:47 PM
Study NCT ID:
NCT00478556
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2007-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007472', 'term': 'Iohexol'}, {'id': 'D003974', 'term': 'Diatrizoate Meglumine'}], 'ancestors': [{'id': 'D014283', 'term': 'Triiodobenzoic Acids'}, {'id': 'D007463', 'term': 'Iodobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'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': 'D008536', 'term': 'Meglumine'}, {'id': 'D013012', 'term': 'Sorbitol'}, {'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D003973', 'term': 'Diatrizoate'}, {'id': 'D006595', 'term': 'Hexosamines'}, {'id': 'D000606', 'term': 'Amino Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lnelson@uabmc.edu', 'phone': '205-934-4015', 'title': 'Lisa Nelson', 'organization': 'UAB Hospital Radiology'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Study was completed.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Gastroview', 'description': 'Oral Gastroview prior to CT', 'otherNumAtRisk': 151, 'otherNumAffected': 0, 'seriousNumAtRisk': 151, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Omnipaque', 'description': 'Oral Omnipaque prior to CT', 'otherNumAtRisk': 149, 'otherNumAffected': 0, 'seriousNumAtRisk': 149, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Preferred Contrast Agent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gastroview', 'description': 'Oral Gastroview prior to CT'}, {'id': 'OG001', 'title': 'Omnipaque', 'description': 'Oral Omnipaque prior to CT'}], 'classes': [{'title': 'Prefer Gastroview', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Prefer Omnipaque', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}, {'title': 'No Preference', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in proportions', 'paramValue': '62', 'groupDescription': 'All individuals tasted both preparations and indicated preference. A binomial test of proportion was done to see if these values differed from 50%.', 'statisticalMethod': 'Binomial test of proportion', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'tested if values were different from 50%'}], 'paramType': 'NUMBER', 'timeFrame': '1 Day', 'description': 'The primary outcome variable is the taste test when subjects will be asked which preparation they prefer. Possible answers include Onmipaque, Gastroview or neither.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was per protocol'}, {'type': 'SECONDARY', 'title': 'Bowel Opacification Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gastroview', 'description': 'Oral Gastroview prior to CT'}, {'id': 'OG001', 'title': 'Omnipaque', 'description': 'Oral Omnipaque prior to CT'}], 'classes': [{'categories': [{'measurements': [{'value': '8.57', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '8.85', 'spread': '1.71', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.270', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Wilcoxon Rank Sum test was used to assess differences in bowel opacification score between the two groups.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Collected day of study', 'description': 'The bowel opacification score was calculated by adding values for stomach, duodenum, jejunum and ileum for each patient. They were averaged across two doctors who read the studies. Scores can range from 0 (no opacification) to 3 (excellent) for each segment and from 0 to 12 for bowel opacification score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol - all patients had usable data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gastroview Group', 'description': 'Patients will be given oral Gastroview (contrast) prior to Computerized Tomography (CT).'}, {'id': 'FG001', 'title': 'Omnipaque Group', 'description': 'Patients ill be given oral Omnipaque (contrast) prior to Computerized Tomography (CT).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients will be randomized to receive either a standardized dilution of Gastroview or Omnipaque orally. The two agents will be prepared to have nearly equivalent iodine concentration.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Gastroview', 'description': 'Oral Gastroview prior to CT'}, {'id': 'BG001', 'title': 'Omnipaque', 'description': 'Oral Omnipaque prior to CT'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56', 'spread': '15', 'groupId': 'BG000'}, {'value': '57', 'spread': '15', 'groupId': 'BG001'}, {'value': '57', 'spread': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-22', 'studyFirstSubmitDate': '2007-05-24', 'resultsFirstSubmitDate': '2010-02-09', 'studyFirstSubmitQcDate': '2007-05-24', 'lastUpdatePostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-05-19', 'studyFirstPostDateStruct': {'date': '2007-05-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preferred Contrast Agent', 'timeFrame': '1 Day', 'description': 'The primary outcome variable is the taste test when subjects will be asked which preparation they prefer. Possible answers include Onmipaque, Gastroview or neither.'}], 'secondaryOutcomes': [{'measure': 'Bowel Opacification Score', 'timeFrame': 'Collected day of study', 'description': 'The bowel opacification score was calculated by adding values for stomach, duodenum, jejunum and ileum for each patient. They were averaged across two doctors who read the studies. Scores can range from 0 (no opacification) to 3 (excellent) for each segment and from 0 to 12 for bowel opacification score.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CT scan', 'oral contrast'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Patients who are scheduled by their health care provider for routine computed tomography (CT) scan will be asked to participate in this study. The primary purpose is to determine if there is a difference in patient preference for Omnipaque versus Gastroview as oral contrast for abdominal pelvic CT. A secondary objective is to evaluate if there is significant difference in bowel opacification for the two agents.', 'detailedDescription': 'Participants must be scheduled for a CT scan prior to enrollment in this study. Informed consent will be obtained from patients acceptable to be included in the study. It will be noted if there is a history of gastrointestinal surgery and if the patient is nauseated before the contrast is administered.\n\nPatients will be randomized to receive either a standardized dilution of Gastroview or Omnipaque orally. The two agents will be prepared to have nearly equivalent iodine concentration. No flavoring agent (ie Crystal Light) will be added. The plan is to mix the agents per manufacturer recommendation as follows:\n\nOmnipaque 350 26cc in 974 cc of water (9.0g iodine) Gastroview 25cc in 1000cc of water (9.17g iodine)\n\nThe time the patients start and stop consuming the contrast as well as the volume taken and time from first drink to start of the scan will be recorded by a blinded investigator. Patients will be asked to drink 900cc. Technical staff will report any side effects or complications observed.\n\nAfter completion of the CT scan, patients will fill in a survey rating the taste of the agent on a 5 point scale, and will be asked to report any side effects. Planned rating scale is as follows:\n\n* 2=Dislike very much\n* 1=Dislike moderately 0=Neither like nor dislike\n\n * 1=Like moderately\n * 2=Like very much\n\nA taste test between the two agents will then be administered by a blinded investigator. Patients will be given 30 cc of each agent. The order in which the agents are administered will be randomized. Patients will be asked to rate preference, if any, for either agent on a 3 point scale. Potential bias related to which agent was administered for the CT will analyzed from the data.\n\nPlanned rating scale is as follows:\n\n* 1- A is better 0 -no difference\n\n * 1- B is better\n\nPatients will be contacted by telephone the day after the CT to assess for any delayed side effects such as diarrhea, constipation, and abdominal cramping experienced in the 24 hours following.\n\nBowel opacification will be rated by 2 body imagers blinded to the agent the patient received. Degree of opacification of the stomach, duodenum, jejunum, and ileum will be rated on a 4 point scale. If contrast has reached the colon, ascending, transverse, descending and sigmoid will be similarly evaluated. Four point rating scale is as follows:\n\n0= absent opacification\n\n1. minimal (\\<25% of analyzed segments opacified)\n2. good (\\>25 % and \\< 75% of analyzed segments opacified)\n3. excellent (\\> 75% of analyzed segments opacified)\n\nDescription of tests/procedures to be performed. Patients will undergo contrast enhanced abdominal pelvis CT as ordered by the referring clinician. Patients will be randomized to either dilute Omnipaque or dilute Gastroview for oral contrast. Both agents will be in a concentration of 9 mg of iodine/ml, and a volume of 900 cc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients at least 19 years of age scheduled for outpatient contrast enhanced abdominal pelvic CT at The Kirklin Clinic in Birmingham Alabama as part of clinical care with the patient's provider will be screened for eligibility.\n\nExclusion Criteria:\n\n* Not competent to give consent.\n* Pregnant.\n* Known allergy to either of the contrast agents.\n* Loss of sense of taste or smell.\n* Contraindication to oral administration such as aspiration risk."}, 'identificationModule': {'nctId': 'NCT00478556', 'briefTitle': 'Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT', 'orgStudyIdInfo': {'id': 'F070208011'}, 'secondaryIdInfos': [{'id': 'Omnipaque vs Gastroview Oral', 'type': 'OTHER', 'domain': 'Department Name'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Gastroview', 'interventionNames': ['Drug: Gastroview']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Omnipaque', 'interventionNames': ['Drug: Omnipaque']}], 'interventions': [{'name': 'Omnipaque', 'type': 'DRUG', 'otherNames': ['Iohexol'], 'description': 'Oral CT contrast', 'armGroupLabels': ['2']}, {'name': 'Gastroview', 'type': 'DRUG', 'otherNames': ['diatrizoate meglumine and diatrizoate sodium solution USP'], 'description': 'Oral CT contrast', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'The Kirklin Clinic', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Michelle McNamara, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'GE Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michelle McNamara, MD', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}