Comparison of Clenpiq vs Golytely Bowel Preparation

February 11, 2021 updated by: Carol Burke, MD, The Cleveland Clinic

Randomized Comparison of the Impact of Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Versus Polyethylene Glycol Bowel Preparation on Inpatient Colonoscopy Quality Parameters

This is a prospective randomized study which will be done at main campus Cleveland Clinic. The investigators will be comparing the colon cleansing by the Boston Bowel Preparation Scale in participants undergoing colonoscopy as an inpatient at our hospital. Participants will be randomized to the the standard of care (4 Liter polyethylene glycol based preparation) or a low volume bowel preparation (sodium picosulfate, a stimulant laxative, magnesium oxide and anhydrous citric acid (SP/MC)). Both agents will either be administered as full dose the evening before or as split-dose on the evening before and on the day of the procedure.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The purpose of our study is to determine if a 4L bowel cleansing agent is more effective than a low volume bowel preparation, and if the time of dosing (single dose night before vs split dose) of the bowel preparation results in better bowel cleansing in participants undergoing colonoscopy. Eligible participants undergoing colonoscopy with conscious sedation will be randomly assigned to one of two bowel preparations and one of two dosing schemas of bowel preparation. Participants not eligible for conscious sedation and are undergoing colonoscopy with general anesthesia will be randomized only to the single dose arms of the study. Participants will complete a questionnaire while drinking the bowel preparation to determine timing and tolerability of the bowel preparation.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Patients who need a colonoscopy while in the hospital (Cleveland Clinic main campus) will be eligible to participate.

Exclusion Criteria:

  • Creatinine clearance less than 30 ml/min
  • History of heart failure with current shortness of breath at rest causing limited physical activity, arrhythmia, unstable angina or acute myocardial infarction
  • Small bowel obstruction, ileus or bowel perforation
  • Dementia or cognitive dysfunction to an extent that they cannot perform the study related documentation or consent to participate in the study.
  • Gastroparesis
  • Toxic megacolon or undergoing colonoscopy for decompression
  • Taking oral tetracyclines, fluoroquinolones, antibiotics, iron, digoxin, chlorpromazine and penicillamine within 2 hours before or 6 hours after administration of Clenpiq or stimulant laxatives within 24 hours
  • History of prior colorectal surgery
  • Allergy to any of the ingredients in Clenpiq or golytely
  • if the procedure is planned in the intensive care unit (ICU)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Participants in Group A will begin drinking the bowel preparation Golytely (4 liter Polyethylene glycol based preparation) at 4:00 PM on the day before colonoscopy - an 8-ounce glass of the bowel preparation every 10 minutes. Participants must finish drinking the bowel preparation by 7:00 PM, and may continue to drink clear liquids until midnight.
Drug: Golytely
bowel preparation
Other Names:
  • polyethylene glycol 3350 and electrolytes oral solution
Active Comparator: Group B
Participants in Group B will begin drinking the bowel preparation Golytely (4 liter Polyethylene glycol based preparation) at 4:00 PM on the day before colonoscopy - an 8-ounce glass of the bowel preparation every 10 minutes for a total of 8 glasses, and must complete drinking the bowel preparation by 5:30 PM. Participants may continue to drink clear liquids until midnight. The next day, 4 hours before the scheduled time of colonoscopy, participants will be asked to drink an 8 ounce glass of bowel preparation every ten minutes for a total of 8 glasses over no more than 1.5 hours. Participants may continue to drink clear liquids until 2 hours before the scheduled time of colonoscopy.
Drug: Golytely
bowel preparation
Other Names:
  • polyethylene glycol 3350 and electrolytes oral solution
Active Comparator: Group C
Participants in Group C will begin drinking the bowel preparation Clenpiq (sodium picosulfate, magnesium oxide, and citric acid) at 4:00 PM on the day before colonoscopy. Participants will be asked to drink 5 ounces of the bowel preparation and at least five (5) additional 8-ounce glasses of clear liquids by 9:00 PM. At 10:00 PM, participants will drink another 5 ounces of the bowel preparation, and will then be asked to drink at least three (3) additional glasses of clear liquids by midnight.
Drug: Clenpiq
bowel preparation
Other Names:
  • sodium picosulfate, magnesium oxide, anhydrous citric acid
Active Comparator: Group D
Participants in Group D will begin drinking the bowel preparation Clenpiq (sodium picosulfate, magnesium oxide, and citric acid) at 4:00 PM on the day before colonoscopy. Participants will be asked to drink 5 ounces of the bowel preparation and at least five (5) additional 8-ounce glasses of clear liquids by 9:00 PM, and may continue drinking clear liquids until midnight. The next day, 4 hours before the scheduled time of colonoscopy, participants will drink another 5 ounces of the bowel preparation and at least three (3) 8 ounce glasses of clear liquids within the next 2 hours. Participants may continue to drink clear liquids until 2 hours before the scheduled time of colonoscopy.
Drug: Clenpiq
bowel preparation
Other Names:
  • sodium picosulfate, magnesium oxide, anhydrous citric acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Satisfactory Bowel Cleansing
Time Frame: 1 day
Bowel cleansing efficacy will be measured using the Boston Bowel Prep Scale (BBPS). The BBPS divides the colon into 3 segments (right, transverse, left); each is scored from 0-3 (0=colonic mucosa not seen due to solid stool that cannot be cleared, 1=only a portion of the mucosa of the colon segment is seen due to staining, residual stool and/or opaque liquid, 2=minor amount of residual staining, small fragments of stool and/or opaque liquid but mucosa of colon segment is seen well, and 3=entire mucosa is seen well with no residual staining, small fragments of stool or opaque liquid). A total BBPS score of 6 or greater AND 2 or greater in all segments will be defined as satisfactory bowel prep. BBPS score of less than 6 or less than 2 in any segment of the colon will be taken as unsatisfactory bowel cleansing in the final analysis.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Requiring a Repeat Colonoscopy
Time Frame: 1 day
Participants requiring a repeat procedure due to unsatisfactory bowel prep
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

Ferring Pharmaceuticals

Investigators

  • Principal Investigator: Carol Burke, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2018

Primary Completion (Actual)

March 26, 2019

Study Completion (Actual)

March 26, 2019

Study Registration Dates

First Submitted

June 22, 2017

First Submitted That Met QC Criteria

June 22, 2017

First Posted (Actual)

June 26, 2017

Study Record Updates

Last Update Posted (Actual)

March 4, 2021

Last Update Submitted That Met QC Criteria

February 11, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-127

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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