Testing How Well Magnesium Citrate Capsules Work as Preparation for a Colonoscopy
NCT ID: NCT03247595
Last Updated: 2021-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2017-09-26
2020-06-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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Polyethylene Glycol
Polyethylene Glycol 3350: 4 Liters
Polyethylene Glycol 3350
4 liters of Polyethylene Glycol for colonoscopy preparation
Magnesium Citrate Capsules
36 Magnesium citrate capsules
Magnesium Citrate Capsules
36 magnesium citrate gelatin capsules
Dulcolax Tablets
4 Dulcolox Tablets
Interventions
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Magnesium Citrate Capsules
36 magnesium citrate gelatin capsules
Polyethylene Glycol 3350
4 liters of Polyethylene Glycol for colonoscopy preparation
Dulcolax Tablets
4 Dulcolox Tablets
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* On PPI and unable to stop for five days before colonoscopy
* On H2 blockers and unable to stop for two days before colonoscopy
* achlorhydria
* Previous colon surgery
* 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
* 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
* Pregnant women
18 Years
ALL
No
Sponsors
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LifeBridge Health
OTHER
Responsible Party
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Principal Investigators
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Ethan Dubin, MD
Role: PRINCIPAL_INVESTIGATOR
LifeBridge Health
Locations
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Woodholme Gastroenterology
Baltimore, Maryland, United States
Sinai Hospital
Baltimore, Maryland, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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1031752
Identifier Type: -
Identifier Source: org_study_id
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