Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-06-08 @ 12:50 PM
Study NCT ID:
NCT03247595
Status:
COMPLETED
Last Update Posted:
2021-03-09
First Post:
2017-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing How Well Magnesium Citrate Capsules Work as Preparation for a Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C110422', 'term': 'magnesium citrate'}, {'id': 'C000595212', 'term': 'polyethylene glycol 3350'}, {'id': 'D001726', 'term': 'Bisacodyl'}], 'ancestors': [{'id': 'D003408', 'term': 'Cresols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': "The endoscopist who reports colon cleanliness is blinded to the subject's assignment."}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'One arm receives Polyethelyne Glycol colonoscopy preparation and the other arm receives magnesium citrate capsules colonoscopy preparation.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-08', 'studyFirstSubmitDate': '2017-08-09', 'studyFirstSubmitQcDate': '2017-08-09', 'lastUpdatePostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Colon Cleanliness', 'timeFrame': 'During colonoscopy', 'description': 'Boston scale rating of colon cleanliness'}], 'secondaryOutcomes': [{'measure': 'Patient compliance and satisfaction', 'timeFrame': 'On the day of colonoscopy', 'description': "Patient's experience recorded in a questionnaire"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colonoscopy preparation', 'Magnesium Citrate Capsules'], 'conditions': ['Colonoscopy']}, 'referencesModule': {'references': [{'pmid': '19240699', 'type': 'BACKGROUND', 'citation': 'Rex DK, Johnson DA, Anderson JC, Schoenfeld PS, Burke CA, Inadomi JM; American College of Gastroenterology. American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. Am J Gastroenterol. 2009 Mar;104(3):739-50. doi: 10.1038/ajg.2009.104. Epub 2009 Feb 24.'}, {'pmid': '17198066', 'type': 'BACKGROUND', 'citation': 'Kastenberg D, Barish C, Burack H, Dalke DD, Duckor S, Putnam W, Valenzuela G; INKP-100 Study Group. Tolerability and patient acceptance of sodium phosphate tablets compared with 4-L PEG solution in colon cleansing: combined results of 2 identically designed, randomized, controlled, parallel group, multicenter phase 3 trials. J Clin Gastroenterol. 2007 Jan;41(1):54-61. doi: 10.1097/01.mcg.0000212662.66644.76.'}, {'pmid': '22192423', 'type': 'BACKGROUND', 'citation': 'Flemming JA, Vanner SJ, Hookey LC. Split-dose picosulfate, magnesium oxide, and citric acid solution markedly enhances colon cleansing before colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2012 Mar;75(3):537-44. doi: 10.1016/j.gie.2011.09.018. Epub 2011 Dec 21.'}, {'pmid': '2407766', 'type': 'BACKGROUND', 'citation': 'Lindberg JS, Zobitz MM, Poindexter JR, Pak CY. Magnesium bioavailability from magnesium citrate and magnesium oxide. J Am Coll Nutr. 1990 Feb;9(1):48-55. doi: 10.1080/07315724.1990.10720349.'}, {'pmid': '24629422', 'type': 'BACKGROUND', 'citation': 'Calderwood AH, Schroy PC 3rd, Lieberman DA, Logan JR, Zurfluh M, Jacobson BC. Boston Bowel Preparation Scale scores provide a standardized definition of adequate for describing bowel cleanliness. Gastrointest Endosc. 2014 Aug;80(2):269-76. doi: 10.1016/j.gie.2014.01.031. Epub 2014 Mar 12.'}, {'pmid': '11726845', 'type': 'BACKGROUND', 'citation': 'Kastenberg D, Chasen R, Choudhary C, Riff D, Steinberg S, Weiss E, Wruble L. Efficacy and safety of sodium phosphate tablets compared with PEG solution in colon cleansing: two identically designed, randomized, controlled, parallel group, multicenter phase III trials. Gastrointest Endosc. 2001 Dec;54(6):705-13. doi: 10.1067/mge.2001.119733.'}]}, 'descriptionModule': {'briefSummary': 'This study compares a colonoscopy preparation composed of magnesium citrate capsules to a preparation of polyethylene glycol solution. The hypothesis is that the magnesium citrate capsules work as well and are better liked by patients due to the lack of taste.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Scheduled for colonoscopy at Sinai Hospital or Woodholme GI Associates\n\nExclusion Criteria:\n\n* • Calculated creatinine clearance under 30ml/min\n\n * On PPI and unable to stop for five days before colonoscopy\n * On H2 blockers and unable to stop for two days before colonoscopy\n * achlorhydria\n * Previous colon surgery\n * Cardiovascular disease, including uncontrolled congestive heart failure, unstable angina pectoris, or recent (3 months) percutaneous transluminal coronary angioplasty, myocardial infarction, or coronary artery bypass graft surgery\n * Colon disease, including chronic constipation (\\<2 bowel movements per week for \\>1 year), ileus and/or acute obstruction, ileostomy, right or transverse colostomy, subtotal colectomy (≥50% of colon removed) with ileosigmoidostomy, hypomotility syndrome, megacolon, or idiopathic pseudo-obstruction\n * Pregnant women'}, 'identificationModule': {'nctId': 'NCT03247595', 'briefTitle': 'Testing How Well Magnesium Citrate Capsules Work as Preparation for a Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'LifeBridge Health'}, 'officialTitle': 'Efficacy of Magnesium Citrate Capsules in Colonoscopy Preparation: A Randomized, Investigator-blinded Non-inferiority Trial Using Polyethylene Glycol as the Active Control.', 'orgStudyIdInfo': {'id': '1031752'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Polyethylene Glycol', 'description': 'Polyethylene Glycol 3350: 4 Liters', 'interventionNames': ['Other: Polyethylene Glycol 3350']}, {'type': 'EXPERIMENTAL', 'label': 'Magnesium Citrate Capsules', 'description': '36 Magnesium citrate capsules', 'interventionNames': ['Dietary Supplement: Magnesium Citrate Capsules', 'Other: Dulcolax Tablets']}], 'interventions': [{'name': 'Magnesium Citrate Capsules', 'type': 'DIETARY_SUPPLEMENT', 'description': '36 magnesium citrate gelatin capsules', 'armGroupLabels': ['Magnesium Citrate Capsules']}, {'name': 'Polyethylene Glycol 3350', 'type': 'OTHER', 'description': '4 liters of Polyethylene Glycol for colonoscopy preparation', 'armGroupLabels': ['Polyethylene Glycol']}, {'name': 'Dulcolax Tablets', 'type': 'OTHER', 'description': '4 Dulcolox Tablets', 'armGroupLabels': ['Magnesium Citrate Capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21208', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Woodholme Gastroenterology', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sinai Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Ethan Dubin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LifeBridge Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LifeBridge Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}