Comparison of Clenpiq vs Golytely Bowel Preparation

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03198221
• Collaborator: Ferring Pharmaceuticals (Industry)
• Enrollment: 14
• Location: 1
• Arms: 4
• Actual Duration (Months): 8.5
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Bowel Preparation Solutions	Drug: Golytely; Drug: Clenpiq	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants will be receive either Golytely or Clenpiq bowel prep solutions. 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 colonoscopy procedure.Participants will be receive either Golytely or Clenpiq bowel prep solutions. 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 colonoscopy procedure.
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Randomized Comparison of the Impact of Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Versus Polyethylene Glycol Bowel Preparation on Inpatient Colonoscopy Quality Parameters
• Actual Study Start Date: Jul 11, 2018
• Actual Primary Completion Date: Mar 26, 2019
• Actual Study Completion Date: Mar 26, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Satisfactory Bowel Cleansing [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.

Secondary Outcome Measures

1. Proportion of Participants Requiring a Repeat Colonoscopy [1 day]

   Participants requiring a repeat procedure due to unsatisfactory bowel prep

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic
• Ferring Pharmaceuticals

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 8, 2019

More Information

Publications

None provided.

• Responsible Party: Carol Burke, MD, Staff, Department of Gastroenterology/Hepatology, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT03198221
• Other Study ID Numbers: 17-127
• First Posted: Jun 26, 2017
• Last Update Posted: Mar 4, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Carol Burke, MD, Staff, Department of Gastroenterology/Hepatology, The Cleveland Clinic: Golytely, Clenpiq, bowel prep
• Additional relevant MeSH terms: Picosulfate sodium; Magnesium Oxide; Polyethylene glycol 3350; Citric Acid

Study Results

Participant Flow

Arm/Group Title	Group A	Group B	Group C	Group D
Arm/Group Description	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. Golytely: bowel preparation	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. Golytely: bowel preparation	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. Clenpiq: bowel preparation	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. Clenpiq: bowel preparation
Period Title: Overall Study
STARTED	3	2	7	2
COMPLETED	3	2	7	2
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Group A	Group B	Group C	Group D	Total
Arm/Group Description	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. Golytely: bowel preparation	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. Golytely: bowel preparation	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. Clenpiq: bowel preparation	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. Clenpiq: bowel preparation	Total of all reporting groups
Overall Participants	3	2	7	2	14
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.7 (12.7)	42.5 (23.3)	51.7 (21.9)	58.0 (22.6)	52.1 (18.7)
Sex: Female, Male (Count of Participants)
Female	2 66.7%	1 50%	3 42.9%	0 0%	6 42.9%
Male	1 33.3%	1 50%	4 57.1%	2 100%	8 57.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	1 14.3%	1 50%	2 14.3%
White	3 100%	2 100%	6 85.7%	1 50%	12 85.7%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Satisfactory Bowel Cleansing
Description	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.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A	Group B	Group C	Group D
Arm/Group Description	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. Golytely: bowel preparation	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. Golytely: bowel preparation	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. Clenpiq: bowel preparation	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. Clenpiq: bowel preparation
Measure Participants	3	2	7	2
Count of Participants [Participants]	2 66.7%	2 100%	4 57.1%	2 100%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A	Group B	Group C	Group D
Arm/Group Description	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. Golytely: bowel preparation	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. Golytely: bowel preparation	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. Clenpiq: bowel preparation	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. Clenpiq: bowel preparation
Measure Participants	3	2	7	2
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%

Adverse Events

Time Frame	Data were collected over the space of 9 months
Adverse Event Reporting Description	Participants were observed for Adverse Events during the study procedure, and at any routine follow-up visits.
Arm/Group Title	Group A		Group B		Group C		Group D
Arm/Group Description	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. Golytely: bowel preparation		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. Golytely: bowel preparation		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. Clenpiq: bowel preparation		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. Clenpiq: bowel preparation
All Cause Mortality
	Group A		Group B		Group C		Group D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/2 (0%)		0/7 (0%)		0/2 (0%)
Serious Adverse Events
	Group A		Group B		Group C		Group D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/2 (0%)		0/7 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Group A		Group B		Group C		Group D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/2 (0%)		0/7 (0%)		0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.