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

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ClinicalTrials.gov Identifier: NCT03247595
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
LifeBridge Health

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.

Condition or disease Intervention/treatment
Colonoscopy Dietary Supplement: Magnesium Citrate Capsules Other: Polyethylene Glycol 3350 Other: Dulcolax Tablets

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
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.
Masking: Single (Investigator)
Masking Description: The endoscopist who reports colon cleanliness is blinded to the subject's assignment.
Primary Purpose: Screening
Official Title: Efficacy of Magnesium Citrate Capsules in Colonoscopy Preparation: A Randomized, Investigator-blinded Non-inferiority Trial Using Polyethylene Glycol as the Active Control.
Anticipated Study Start Date : August 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : September 2018


Arm Intervention/treatment
Active Comparator: Polyethylene Glycol
Polyethylene Glycol 3350: 4 Liters
Other: Polyethylene Glycol 3350
4 liters of Polyethylene Glycol for colonoscopy preparation
Experimental: Magnesium Citrate Capsules
36 Magnesium citrate capsules
Dietary Supplement: Magnesium Citrate Capsules
36 magnesium citrate gelatin capsules
Other: Dulcolax Tablets
4 Dulcolox Tablets



Primary Outcome Measures :
  1. Colon Cleanliness [ Time Frame: During colonoscopy ]
    Boston scale rating of colon cleanliness


Secondary Outcome Measures :
  1. Patient compliance and satisfaction [ Time Frame: On the day of colonoscopy ]
    Patient's experience recorded in a questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03247595


Contacts
Contact: Ethan Dubin, MD 4103562306 ethandubin@yahoo.com

Locations
United States, Maryland
Woodholme Gastroenterology Recruiting
Baltimore, Maryland, United States, 21208
Principal Investigator: Ethan Dubin, MD         
Sub-Investigator: Lila Tarmin, MD         
Sinai Hospital Recruiting
Baltimore, Maryland, United States, 21215
Sub-Investigator: Sudhir Dutta, MD         
Sub-Investigator: Rakesh Vinayek, MD         
Sub-Investigator: Hugh Mai, MD         
Sponsors and Collaborators
LifeBridge Health
Investigators
Principal Investigator: Ethan Dubin, MD LifeBridge Health

Publications:

Responsible Party: LifeBridge Health
ClinicalTrials.gov Identifier: NCT03247595     History of Changes
Other Study ID Numbers: 1031752
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by LifeBridge Health:
Colonoscopy preparation
Magnesium Citrate Capsules

Additional relevant MeSH terms:
Citric Acid
Magnesium citrate
Polyethylene glycol 3350
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Cathartics
Gastrointestinal Agents
Laxatives