Testing How Well Magnesium Citrate Capsules Work as Prepa... | NCT03247595

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

NCT03247595

Sponsor

LifeBridge Health

Status

Completed

Last Update Posted

Mar 9, 2021Actual

Enrollment

62Actual

Phase

Not Applicable

Conditions

Colonoscopy

Interventions

Magnesium Citrate Capsules
Polyethylene Glycol 3350
Dulcolax Tablets

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 26, 2017Actual

Primary Completion Date

Jun 16, 2020Actual

Completion Date

Jun 16, 2020Actual

First Submitted Date

Aug 9, 2017

First Submission Date that Met QC Criteria

Aug 9, 2017

First Posted Date

Aug 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2021

Last Update Posted Date

Mar 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Polyethylene Glycol	Active Comparator	Polyethylene Glycol 3350: 4 Liters	Other: Polyethylene Glycol 3350
Magnesium Citrate Capsules	Experimental	36 Magnesium citrate capsules	Dietary Supplement: Magnesium Citrate Capsules Other: Dulcolax Tablets

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnesium Citrate Capsules	Dietary Supplement	36 magnesium citrate gelatin capsules	Magnesium Citrate Capsules

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Colon Cleanliness	Boston scale rating of colon cleanliness	During colonoscopy

Secondary Outcomes

Measure	Description	Time Frame
Patient compliance and satisfaction	Patient's experience recorded in a questionnaire	On the day of colonoscopy

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ethan Dubin, MD	LifeBridge Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Woodholme Gastroenterology		Baltimore	Maryland	21208	United States
Sinai Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19240699	Background	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.
17198066	Background

ID	Term
C110422	magnesium citrate
C000595212	polyethylene glycol 3350
D001726	Bisacodyl

ID	Term
D003408	Cresols
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic