Efficacy of Magnesium Citrate Capsules in Colonoscopy Preparation: A Randomized, Investigator-blinded Non-inferiority Trial Using Polyethylene Glycol as the Active Control.

Testing How Well Magnesium Citrate Capsules Work as Preparation for a Colonoscopy



Sponsors

Lead Sponsor



Source

LifeBridge Health

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No

Is Us Export

No


Brief Summary

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.

Overall Status

Recruiting

Start Date

2017-08-01

Completion Date

2018-09-01

Primary Completion Date

2018-08-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Colon Cleanliness
During colonoscopy

Secondary Outcome

Measure

Time Frame

Patient compliance and satisfaction
On the day of colonoscopy

Enrollment

180

Condition


Intervention

Intervention Type

Dietary Supplement

Intervention Name


Description

36 magnesium citrate gelatin capsules with 4 dulcolox tablets.

Arm Group Label

Magnesium Citrate Capsules


Intervention Type

Other

Intervention Name


Description

4 liters of Polyethylene Glycol for colonoscopy preparation

Arm Group Label

Polyethylene Glycol



Eligibility

Criteria

Inclusion Criteria:

- • Scheduled for colonoscopy at Sinai Hospital or Woodholme GI Associates

Exclusion Criteria:

- • Calculated creatinine clearance under 30ml/min

- 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

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Ethan Dubin, MD
Principal Investigator
LifeBridge Health

Overall Contact

Last Name

Ethan Dubin, MD

Phone

4103562306

Email

[email protected]


Location

Facility

Status

Investigator

Woodholme Gastroenterology
Baltimore Maryland 21208 United States
Recruiting
Last Name: Ethan Dubin, MD
Role: Principal Investigator

Last Name: Lila Tarmin, MD
Role: Sub-Investigator

Sinai Hospital
Baltimore Maryland 21215 United States
Recruiting
Last Name: Sudhir Dutta, MD
Role: Sub-Investigator

Last Name: Rakesh Vinayek, MD
Role: Sub-Investigator

Last Name: Hugh Mai, MD
Role: Sub-Investigator


Location Countries

Country

United States


Verification Date

2017-08-01

Lastchanged Date

2017-08-09

Firstreceived Date

2017-08-09

Responsible Party

Responsible Party Type

Sponsor


Keywords


Has Expanded Access

No

Number Of Arms

2

Intervention Browse

Mesh Term

Citric Acid

Magnesium citrate

Polyethylene glycol 3350



Arm Group

Arm Group Label

Polyethylene Glycol

Arm Group Type

Active Comparator

Description

Polyethylene Glycol 3350


Arm Group Label

Magnesium Citrate Capsules

Arm Group Type

Experimental

Description

Magnesium citrate capsules and 4 Dulcolox Tablets



Firstreceived Results Date

N/A

Reference

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. Erratum in: Am J Gastroenterol. 2009 Jun;104(6):1613.

PMID

19240699


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.

PMID

17198066


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

22192423


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.

PMID

2407766


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

24629422


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.

PMID

11726845



Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Intervention Model Description

One arm receives Polyethelyne Glycol colonoscopy preparation and the other arm receives magnesium citrate capsules colonoscopy preparation.

Primary Purpose

Screening

Masking

Investigator

Masking Description

The endoscopist who reports colon cleanliness is blinded to the subject's assignment.



ClinicalTrials.gov processed this data on August 11, 2017

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Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
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In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

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