Comparison of Clenpiq vs Golytely Bowel Preparation

NCT ID: NCT03198221

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-11
• Study Completion Date: 2019-03-26

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.

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.

Conditions

Bowel Preparation Solutions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Golytely

Intervention Type: DRUG

bowel preparation

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.

Group Type: ACTIVE_COMPARATOR

Golytely

Intervention Type: DRUG

bowel preparation

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.

Group Type: ACTIVE_COMPARATOR

Clenpiq

Intervention Type: DRUG

bowel preparation

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.

Group Type: ACTIVE_COMPARATOR

Clenpiq

Intervention Type: DRUG

bowel preparation

Interventions

Golytely

bowel preparation

Intervention Type: DRUG

Clenpiq

bowel preparation

Intervention Type: DRUG

Other Intervention Names

polyethylene glycol 3350 and electrolytes oral solution; sodium picosulfate, magnesium oxide, anhydrous citric acid

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Carol Burke, MD

Staff, Department of Gastroenterology/Hepatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carol Burke, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17-127

Identifier Type: -

Identifier Source: org_study_id