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OpenTrials
Completed

NCT Number: NCT03247595

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

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.

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Key information

Conditions

Colonoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sinai Hospital, Baltimore, Maryland, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium Citrate Capsules

Dietary Supplement

36 magnesium citrate gelatin capsules

Polyethylene Glycol 3350

Other

4 liters of Polyethylene Glycol for colonoscopy preparation

Dulcolax Tablets

Other

4 Dulcolox Tablets

Primary outcomes

  1. Colon Cleanliness

    Time frame: During colonoscopy

    Boston scale rating of colon cleanliness

Secondary outcomes

  1. Patient compliance and satisfaction

    Time frame: On the day of colonoscopy

    Patient's experience recorded in a questionnaire

Sponsors and collaborators

Lead sponsor

LifeBridge Health

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 11, 2017
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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