Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
Study NCT ID:
NCT01209806
Status:
COMPLETED
Last Update Posted:
2019-07-15
First Post:
2010-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Moviprep With Simethicone on Colonic Bubbles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-08-21', 'releaseDate': '2019-08-01'}, {'resetDate': '2023-12-19', 'releaseDate': '2023-11-28'}], 'estimatedResultsFirstSubmitDate': '2019-08-01'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D012841', 'term': 'Simethicone'}], 'ancestors': [{'id': 'D004129', 'term': 'Dimethylpolysiloxanes'}, {'id': 'D012828', 'term': 'Silicones'}, {'id': 'D012833', 'term': 'Siloxanes'}, {'id': 'D017646', 'term': 'Organosilicon Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-12', 'studyFirstSubmitDate': '2010-07-12', 'studyFirstSubmitQcDate': '2010-09-24', 'lastUpdatePostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy - Entire colon', 'timeFrame': 'At time of colonoscopy', 'description': 'Successful cleansing defined as score or excellent or good Unsuccessful cleansing defined as score of fair or inadequate'}], 'secondaryOutcomes': [{'measure': 'Efficacy - Right colon', 'timeFrame': 'At time of colonoscopy', 'description': 'Successful cleansing defined as score or excellent or good Unsuccessful cleansing defined as score of fair or inadequate'}, {'measure': 'Adenoma detection', 'timeFrame': 'at time of colonoscopy', 'description': 'Defined as number of adenoma/patient Secondarily evaluate % of patients with at least 1 adenoma'}, {'measure': 'Flushing', 'timeFrame': 'at time of colonoscopy', 'description': 'Defined as need for any (1, 2, or 3) flushing\n\n• 0 = none, 1 = \\<50 ml, 2 = 50-100 ml, 3 = \\>100 ml'}, {'measure': 'Tolerance', 'timeFrame': 'during prep ingestion', 'description': 'Prep completion\n\n• Completion defined as consuming \\> 90%\n\nSleep\n\n* Primary definition as quality of sleep\n* Also evaluate duration of sleep Overall satisfaction\n* Use visual analogue (Likert) scale Adverse events - nausea, vomiting, abdominal pain, bloating, light-headedness\n* Primary is incidence\n* Secondary is severity using Likert scale'}, {'measure': 'Safety', 'timeFrame': 'at time of colonoscopy', 'description': 'Vitals with orthostatic measures (BP, Pulse) day of colonoscopy Physical exam'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bubbles in Colon at Time of Colonoscopy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the administration of PEG along with simethicone will reduce the incidence of colonic bubbles that interfere with polyp detection.', 'detailedDescription': 'evaluating if simethicone is better than placebo at decreasing gas in the colon at time of colonoscopy so that it is easier for the endoscopist to see polyps'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Elective outpatients undergoing colonoscopy using split dose PEG-ELS with sodium ascorbate and ascorbic acid\n\nExclusion Criteria:\n\n* Unable or unwilling to give informed consent\n* Age \\< 18 years\n* Pregnant\n* Breast feeding\n* Established or suspected gastroparesis\n* Pseudo-obstruction - established or suspected\n* Severe constipation (\\< 1 BM a week)\n* Bowel obstruction\n* Greater than 50% resection of colon\n* Chronic nausea or vomiting\n* Consumed \\> 100% standard dose of PEG-ELS (i.e. more than 2L)\n* G6PD deficiency\n* PEG allergy\n* Significant psychiatric illness'}, 'identificationModule': {'nctId': 'NCT01209806', 'briefTitle': 'The Effects of Moviprep With Simethicone on Colonic Bubbles', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'The Effects of Moviprep With Simethicone on Colonic Bubbles', 'orgStudyIdInfo': {'id': '#09D.472'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'simethicone', 'interventionNames': ['Drug: simethicone']}, {'type': 'NO_INTERVENTION', 'label': 'no simethicone'}], 'interventions': [{'name': 'simethicone', 'type': 'DRUG', 'otherNames': ['Alka-Seltzer® Gas Relief Maximum Strength Softgels®', 'Flatulex® Drops', 'GasAid® Maximum Strength Softgels®', 'Gas-X®', 'Gas-X® Extra Strength', 'Gas-X® Extra Strength Liquid', 'Gas-X® Extra Strength Softgels®', 'Genasyme®', 'Genasyme® Drops', 'Maalox® Anti-Gas Extra Strength', 'Maalox® Anti-Gas Regular Strength', 'Mylanta® Gas Relief', 'Mylanta® Gas Relief Gelcaps®', 'Mylanta® Gas Relief Maximum Strength', "Mylicon® Infant's Drops", 'Phazyme® Infant Drops', 'Phazyme®-125 Softgels®', 'Phazyme®-166 Maximum Strength', 'Phazyme®-166 Maximum Strength Softgels®'], 'description': '400 mg simethicone at 6pm night prior to colonoscopy 400 mg simethicone 4 hours before colonoscopy', 'armGroupLabels': ['simethicone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'David Kastenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-08-01', 'type': 'RELEASE'}, {'date': '2019-08-21', 'type': 'RESET'}, {'date': '2023-11-28', 'type': 'RELEASE'}, {'date': '2023-12-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Thomas Jefferson University'}}}}